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Transcript
STROKE THROMBOLYSIS GUIDELINE
Version 6
1. Aim/Purpose of this Guideline
To deliver safe and effective thrombolysis for acute ischaemic stroke using
robust evidence based clinical criteria.
2. The Guidance
Contents
Reason for change
Thrombolysis pathway
Clinical Exclusions from thrombolysis
Management of hypertension
r-tPA dose ready reckoner
Consent issues
Management of complications after thrombolysis
NIH Stroke Scale (full version)
Nursing protocol and care plan
Short NIHSS score sheet
Peninsula Heart & Stroke Network Clinical Reference Group
statement on thrombolysis
Education and References
Monitoring and Effectiveness and compliance
Governance information
Equality Impact Assessment
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 1 of 29
Page
2
3
5
7
8
9
10
11
18
21
22
24
25
26
28
Referral of Patients with Acute Stroke and Proximal Artery Occlusion for
Consideration of Intra-arterial Treatment at Derriford Hospital
Intravenous thrombolysis has been offered at RCHT since 2008 and the evidence shows that it
improves outcome in patients following ischaemic stroke [1]. There is now evidence also for
mechanical thrombectomy and the inclusion criteria are listed below with discussing evidence for
the procedure on page [2-8]. Early thrombectomy with second-generation stent retriever devices is
safe and effective for reducing disability when used to treat patients with stroke caused by proximal
large artery occlusions. The NNT for one additional person to achieve functional independence in
these trials was 2.6.
Referrals only accepted between the hours of 09:00 and 15:00 Monday to Friday.
Please consider following patients for referral for intra-arterial treatment:

Ischaemic stroke patient-if no improvement within 30 minutes of intravenous
thrombolysis on NIHSS

Demonstration of proximal vessel occlusion CT angiogram (terminal ICA, M1,
proximal M2, basilar), considered responsible for the patient’s presentation

Possibility of clot extraction within 4.5 hours of stroke (time to groin puncture 4
hours).
Exclusion criteria
 Any evidence of haemorrhagic transformation (or primary haemorrhage)

Age greater than 80

Hypodensity involving more than 1/3 of middle cerebral artery territory

Significant comorbidities that reduce the likelihood of a good clinical outcome

Opinion of receiving clinician that clot extraction will be impossible in the required time
How to proceed:
 ED consultant discusses patient with stroke consultant on Phoenix (ext 2120/via
switch)

ED consultant in charge of patients care requests urgent CT angiogram

Stroke consultant contacts on call interventional neuroradiology consultant at
Derriford hospital (via Derriford switchboard).

Large bore iv access and urgent transfer of patient by radiographers (main CT
scanner)

Patient accompanied to scanner by ED nurse (stroke nurse when available)

Images are uploaded PACS as soon as obtained

ED consultant contacts Derriford neuroradiology team once CTA images uploaded
and arranges urgent transfer to Derriford hospital.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 2 of 29
Derriford Hospital # 6171 request the stroke registrar (1908) to arrange bed and
transfer
RCHT STROKE THROMBOLYSIS PATHWAY
PRE-HOSPITAL





Stroke eligible for thrombolysis:
Positive FAST (Face, Arm and Speech Test)
Age 18 or older
Symptoms noted on waking exclude thrombolysis (unless last awake within
thrombolysis window)
Symptom onset to thrombolysis within 6h
No seizure at onset
Check BM, confirm time of onset, transport to ED RCHT, with NOK and list of pills if
available. Pre-alert ED – ensure name, DOB and AFFECTED SIDE included
EMERGENCY DEPARTMENT












Book CT on MAXIMS – ensure side affected is clear on request
Ring 4444 to alert radiographer/stroke nurse/stroke ward
Transport patient straight to CT on arrival for urgent CT head
Brief medical history to confirm time of onset, inclusion and exclusion criteria
Perform NIHSS examination (National Institute Health Stroke Scale)
Brief general examination, estimate weight
BP both arms, repeat higher arm BP after 15 minutes (manual cuff not dynamap)
Manage high BP as per protocol
iv access x2
Urgent bloods = FBC, U&E, clotting, G&S (INR if on warfarin), lipids, glucose
ECG (and CXR if needed)
DVT clinic staff will do point of care INR if on warfarin
CT SCANNER
Radiographer performs scan and informs on call radiologist to report scan
Report should be available within 30 minutes of scan
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 3 of 29
DECISION TO THROMBOLYSE
 Repeat NIHSS to ensure not rapidly improving
 Do not delay while waiting for bloods (unless on warfarin or on chemo or known
haematological disorder)
 Decision to thrombolyse taken by thrombolysing doctor
 Obtain verbal consent if possible
 Calculate dose using ready reckoner, give bolus in 10ml syringe over 1-2
minutes then infusion over 1 hour using 50ml syringe driver
 Start treatment in ED and organise bed on Hyperacute stroke unit (Phoenix
ward), hand over patient to stroke consultant in hours or medical registrar out of
hours
 If no bed available on acute stroke unit contact site coordinator, refer patient to
ITU consultant and ITU nurse and transfer to ITU for 12 hours of monitoring
 If no acute stroke nurse available for 1:2 care transfer patient to ITU (as above)
 If large vessel occlusion suspected (NIHSS >9) please consider referral for intraarterial treatment and CTA (see first page of guidance)
MONITOR FOR COMPLICATIONS
 Watch for signs of neurological deterioration, bleeding, anaphylaxis
 Repeat NIHSS at 30 minutes
 Manual BP, pulse, GCS, respiratory rate, temperature, SaO2 every 15 min for
2h, then every 30 min for 6 h, then every hour for 18h
 Maintain BP Systolic <180 and Diastolic <105, Temperature < 37°C.
 Avoid urinary catheter, nasogastric tube, intramuscular injections for first 24h
 Avoid antiplatelets / anticoagulants until repeat CT at 24h excludes bleeding
 Do not anticoagulate for Atrial fibrillation in first 24 hours after lysis
 Inform medical registrar of any concerns
 Manage complications as per protocol (page 10)
 Prescribe Intermittent compression stockings for VTE prophylaxis
AT 30 min
 If no improvement consider please consider referral for intra-arterial treatment
and CTA (see first page of guidance)
AT 24 HOURS
 Repeat routine CT scan and repeat NIHSS at 24h
 Start antiplatelet treatment as per protocol if no bleeding on repeat CT
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 4 of 29
CLINICAL EXCLUSIONS FROM THROMBOLYSIS
Do not give thrombolysis if you have ticked any ‘YES’ boxes
YES
NO
FROM THE HISTORY
Time of onset unknown
Awoke with symptoms, unless last awake within lysis window
Seizure at onset
Known bleeding diathesis
Arterial puncture at a non-compressible site, or lumbar
puncture, within the last 7 days
Major surgery within the last 14 days
Gastrointestinal or urinary tract haemorrhage within 21 days
Head injury, intracranial surgery or stroke within the last 3
months
Any history of intracranial haemorrhage, brain tumour,
intracranial AVM or aneurysm
TIME OF ONSET
Within 3h – no upper age limit
3 to 4.5h – can treat if 18-80y, patients over 80y do not benefit
4.5 to 6h – patients 18-80 may benefit – needs decision by thrombolysing doctor
ANTICOAGULANTS
Current warfarin treatment is not exclusion if the INR is 1.7 or less.
Current heparin treatment is not an exclusion if the APTT ratio is less than 1.2
Full dose (but not low dose/prophylactic) LMWH is an exclusion
Rivaroxaban/Dabigatran – if a patient is on these treatments, 24h or 12h respectively
should elapse before thrombolysis considered. This excludes these patients from
thrombolysis for stroke.
PREGNANCY
Pregnancy or women who are post-partum – r-tPa is unlicensed for use in pregnancy.
It should not be withheld in pregnant patients with ischaemic stroke, but because
experience is limited, risks and benefits must be carefully weighed and should be
discussed with on-call obstetrician
CHEMOTHERAPY
Some chemotherapy agents may be relative contra-indications to thrombolysis or
patients may be thrombocytopaenic. If patient on chemotherapy drugs please ensure
bloods normal first and check with oncology or haematology before giving lysis
CHILDREN
Alteplase is not licensed for <18y. Studies are ongoing in children. Cases should be
discussed by paediatric team with paediatric neurologists at Bristol.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 5 of 29
ON INITIAL ASSESSMENT
YES
NO
YES
NO
CONFIRM PATIENT ELIGIBLE FOR THROMBOLYSIS
YES
NO
VERBAL CONSENT?
YES
NO
Coma (GCS <8; NIH-SS question 1a = 3)
Minor stroke symptoms
Sensory symptoms only
Dysarthria only
Ataxia only
Minimal weakness not
registering on NIHSS
Partial visual field defect
only
Clinical presentation suggestive of subarachnoid
haemorrhage (even if subsequent CT normal)
DBP>140
or BP>180/105 having received more than 2 doses
labetolol (see management of hypertension page 7)
Capillary glucose <2.7 (Treat as per Trust protocol)
ON LAB RESULTS
Platelets <100 (only wait for FBC if known haematological
disorder or on chemo)
Current warfarin treatment with INR MORE THAN 1.7
Do not start treatment until INR available
Current heparin treatment and APTT > 1.2
Do not start treatment until APTT available
Current treatment with full dose LMWH
Plasma glucose <2.7 (Treat as per Trust protocol)
ON CT SCAN – reported by radiologist
Radiological signs of intracranial haemorrhage
Diffuse swelling of a cerebral hemisphere
SIGNATURE
NAME
DATE
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 6 of 29
TIME
MANAGEMENT OF HYPERTENSION IN POTENTIAL THROMBOLYSIS PATIENTS
Record BP in both arms using Manual cuff
Use arm with highest BP reading thereafter
Repeat after 15 minutes if hypertensive
Blood Pressure < 180
Systolic <105 Diastolic
Systolic > 220 mmHg
And / Or
Diastolic 121-140 mmHg
Systolic >180
And/or
Diastolic >105 mmHg
If Diastolic above 140
mmHg
Monitor BP, do not intervene, Thrombolyse if eligible
*Give IV Labetalol 10 iv over 1-2 minutes
Repeat same or double dose to bring BP down to 180/105
Or Labetalol Infusion 2-8mg/min
*Give IV Labetalol 10 iv over 1-2 minutes
Repeat same or double dose to bring BP down to 180/105
Or Labetalol Infusion 2-8mg/min
patient NOT eligible for Thrombolysis
*If more than 2 doses of labetolol needed Patient NOT eligible for Thrombolysis
In asthma, cardiac failure or 1st degree heart block use Isoket infusion (2-10mg /hr)
Monitoring of BP after Thrombolysis
Blood Pressure after Thrombolysis should be measured
Every 15 minutes for 2 hours
Every 30 minutes for 6 hours
Hourly for 18 hours
During Thrombolysis and afterwards BP should be managed to below 180/105 using the
above instructions – If Blood pressure rises sharply during or after Thrombolysis suspect
Intracranial haemorrhage.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 7 of 29
RtPA DOSE READY RECKONER
Alteplase, Recombinant tissue plasminogen activator
(Actilyse® Boehringer Ingelheim)







One
vial
Two
vials
Unless the patient or companion knows their recent weight, estimate it to the
nearest 5 kg
The total dose of rt-PA is 0.9 mg/kg or 90 mg, whichever is the lesser (Column 5)
Make up one or two vials of rt-PA using the 50 ml diluent in each drug pack, making
a solution of 1 mg/ml rt-PA
Draw up and give 10% as a bolus over 1-2 minutes (Column 3), using a 10 ml
syringe
Draw up the remaining 90% (the ‘infusion dose’, Column 4) into 1 or 2, 50ml
syringes and set up the 50ml syringe driver (IVAC) with the corresponding infusion
rate in mls/hr. This infusion is given over 1h.
Do not give the cardiac dose
Do not give more than 90 mg
1
2
3
4
5
Estimate of
patients
weight (kg)
Equivalent
Imperial
weight
Bolus dose
(mls)
given over 1-2
minutes
Infusion
dose (mls) =
infusion rate
in mls/hr
Total dose
(mg at 1
mg/ml)
45
7 st 1 lb
4
36
40
50
7 st 12 lb
5
40
45
55
8 st 9 lb
5
44
49
60
9 st 6 lb
5
49
54
65
10 st 3 lb
6
52
58
70
11 st 0 lb
6
57
63
75
11 st 11 lb
7
60
67
80
12 st 8 lb
7
65
72
85
13 st 5 lb
7
69
76
90
14 st 2 lb
8
73
81
95
14 st 13 lb
8
77
85
≥100
15 st 10 lb
9
81
90
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 8 of 29
ISSUES AROUND CONSENT
Information for patients / relatives before giving thrombolysis
Thrombolysis with r-tPA is a licensed treatment for acute ischaemic stroke, and written
consent is not required. If possible there should be agreement from the patient and / or
relative.
When the patient cannot agree because of their impairments and no relative is available,
then treatment can still be given if it is judged to be in the best interests of the patient. Any
explanation might include:
 There has been a significant stroke caused by a blocked artery preventing blood
from getting to a part of the brain and causing permanent damage. With or without
treatment there may be some recovery or things could get worse. Stroke is fatal in
about a third of people.
 Only one treatment has been shown to prevent damage to the brain. This treatment
dissolves the blood clot blocking the artery and allows blood to get back to the brain.
It only works if given quickly after the stroke starting and the benefit is greater the
sooner it is given
 There is a slight increased risk of death within the first week (8.9 vs 6.4%), mostly
due to fatal intracranial bleeding (3.6 vs 0.6%). But after the first week there is a
lower chance of death (11.5 vs 13.6%), so several months later there is no
difference in chance of death overall.
 The chances of being alive and independent (Rankin score 0-2) several months later
are higher,
if treated within 3h
If treated 3-6h
if treated within 6h
% chance of
being alive and
independent at 3
months if lysed
% chance of
being alive and
independent at
3 months if not
lysed
40.7%
47.5%
46.3%
31.7%
45.7%
42.1%
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 9 of 29
Absolute benefit –
number of extra
patients alive and
independent at 3
months per 1000
patients treated
90
18
42
MANAGEMENT OF COMPLICATIONS AFTER THROMBOLYSIS
BP commonly drops after initiation of thrombolysis, not necessarily due to bleeding. If this
happens give iv fluid bolus.
Bleeding, by process of de-fibrination, is more common than with heparin (around 3%)
Intracranial bleeding
Should be suspected if there is neurological deterioration, new headache, fall in conscious
level, acute hypertension, seizure, nausea or vomiting
Initial action
Stop infusion of r-tPA, repeat NIHSS, commence iv saline if needed
Arrange urgent CT scan
Check FBC, full coagulation screen, check blood sent for G&S
If CT scan shows bleeding
 Is haemorrhage petechial? If so it is unlikely anything other than stopping r-tPA will be
needed. Continue to observe patient closely
 Is haemorrhage parenchymal?
Give 20% mannitol 200ml stat (dose may be repeated)
Consider tranexamic acid 10 mg iv and 10 units cryoprecipitate
Further advice is available via the intranet anti-coagulation guidelines
Consult neurosurgeon regarding possible transfer for haematoma evacuation
If CT scan shows no bleeding
Recheck patient for other causes of deterioration eg recurrent ischaemic stroke, sepsis,
seizure, metabolic derangement, extracranial bleeding
Extracranial bleeding
Should be suspected if there is shock, drop in BP, evidence of blood loss – although a
high index of suspicion is needed as blood loss may not be obvious.
Initial action
Stop infusion of r-tPA
Check FBC, full coagulation screen, check blood sent for G&S and/or arrange cross match
depending on situation
Commence iv saline or blood transfusion depending on situation
If patient fails to respond to simple measures or there is severe haemorrhage, consider
tranexamic acid 10 mg/kg iv and 10 units cryoprecipitate
Further advice is available from intranet, on call geriatrician and haematologist as above.
Anaphylaxis
Anaphylactic reactions to r-tPA can occur but are rare. If an urticarial rash, peri-orbital
swelling or tongue swelling occur, the r-tPA should be stopped and the patient reviewed by
a doctor urgently.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 10 of 29
NIH STROKE SCALE – full version and master copy – please record patient scores on quick version
(see page 23)
INSTRUCTION
SCALE DEFINITION
1a. Level of Consciousness:
The investigator must choose a response,
even if a full evaluation is prevented by
such obstacles as an endotracheal tube,
language barrier, orotracheal trauma/
bandages. A 3 is scored only if the patient
makes no movement (other than reflexive
posturing) in response to noxious
stimulation.
0 = Alert; keenly responsive.
1 = Not alert, but rousable by minor
stimulation to obey, answer, or respond.
2 = Not alert, requires repeated
stimulation to attend, or is obtunded and
requires strong or painful stimulation to
make movements (not stereotyped).
3 = Coma; Responds only with reflex
motor or autonomic effects, or totally
unresponsive, flaccid, areflexic.
1b. LOC Questions:
The patient is asked the month and his/her
age. The answer must be correct - there is
no partial credit for being close. Aphasic
and stuporous patients who do not
comprehend the questions will score 2.
Patients unable to speak because of
endotracheal intubation, orotracheal
trauma, severe dysarthria from any cause,
language barrier or any other problem not
secondary to aphasia are scored 1. It is
important that only the initial answer be
graded and that the examiner not “help” the
patient with verbal or non-verbal cues.
0 = Answers both questions correctly.
1 = Answers one question correctly.
2 = Answers neither question correctly.
1c. LOC Commands:
The patient is asked to open and close the
eyes and then to grip and release the
nonparetic hand. Substitute another one
step command if the hands cannot be used.
Credit is given if an unequivocal attempt is
made but not completed due to weakness.
If the patient does not respond to
command, the task should be demonstrated
to them (pantomime) and score the result
(i.e., follows none, one, or two commands).
Patients with trauma, amputation, or other
physical impediments should be given
suitable one-step commands. Only the first
attempt is scored.
2. Best Gaze:
Only horizontal eye movements will be
tested. Voluntary or reflexive
(oculocephalic) eye movements will be
scored but caloric testing is not done. If the
patient has a conjugate deviation of the
eyes that can be overcome by voluntary or
reflexive activity, the score will be 1. If a
patient has an isolated peripheral nerve
paresis (CN III, IV, OR VI) score a 1. Gaze
is testable in all aphasic patients. Patients
with ocular trauma, bandages, preexisting
blindness or other disorder of visual acuity
or fields should be tested with reflexive
movements and a choice made by the
0 = Performs both tasks correctly.
1 = Performs one task correctly.
2 = Performs neither task correctly.
0 = Normal
1 = Partial gaze palsy. This score is
given when gaze is abnormal in one or
both eyes, but where forced deviation or
total gaze paresis are not present.
2 = Forced deviation, or total gaze
paresis not overcome by the
oculocephalic manoeuvre
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 11 of 29
SCORE
1
SCORE
2
-----------
-----------
-----------
-----------
-----------
-----------
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-----------
investigator. Establishing eye contact and
then moving about the patient from side to
side will occasionally clarify the presence of
a gaze palsy.
3. Visual:
Visual fields (upper and lower quadrants)
are tested by confrontation, using finger
counting or visual threat as appropriate.
Patient must be encouraged, but if they
look at the side of the moving fingers
appropriately, this can be scored as normal.
If there is unilateral blindness or
enucleation, visual fields in the remaining
eye are scored. Score 1 only if a clear-cut
asymmetry, including quadrantanopia is
found. If patient is blind from any cause
score 3. Double simultaneous stimulation
is performed at this point. If there is
extinction patient receives a 1 and the
results are used to answer question 11.
0 = No visual loss.
1 = Partial hemianopia.
2 = Complete hemianopia.
3 = Bilateral hemianopia (blind including
cortical blindness).
4. Facial Palsy:
Ask, or use pantomime to encourage the
patient to show teeth or raise eyebrows or
close eyes. Score symmetry of grimace in
response to noxious stimuli in the poorly
responsive or non-comprehending patient.
If facial trauma/bandages, orotracheal tube,
tape, or other physical barrier obscures the
face, these should be removed to the extent
possible.
5-8. Motor Arm and Leg:
The limb is placed in the appropriate
position: extend the arms 90 degrees (if
sitting) or 45 degrees (if supine) and the leg
30 degrees (always tested supine). Drift is
scored if the arm falls before 10 seconds or
the leg before 5 seconds. The aphasic
patient is encouraged using urgency in the
voice and pantomime but not noxious
stimulation. Each limb is tested in turn,
beginning with the nonparetic arm. Only in
the case of amputation or joint fusion at the
shoulder or hip may the score be “9” and
the examiner must clearly write the
explanation for scoring as a “9”.
0 = Normal symmetrical movement.
1 = Minor paralysis (flattened nasolabial
fold, asymmetry on smiling).
2 = Partial paralysis (total or near total
paralysis of lower face).
3 = Complete paralysis (absence of facial
movement in the upper and lower face).
-----------
-----------
-----------
-----------
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Arm
0 = No drift, arm holds 90 (or 45) degrees
for full 10 seconds.
1 = Drift, arm holds 90 (45) degrees, but
drifts down before full 10 seconds; does
not hit bed or other support.
2 = Some effort against gravity, limb
cannot get to or maintain (if cued) 90 (or
45) degrees, drifts down to bed, but has
some effort against gravity.
3 = No effort against gravity, arm falls.
4 = No movement.
9 = Amputation, joint fusion -explain:
5.Right Arm
6. Left Arm
Leg
0 = No drift, leg holds 30 degrees position
for full 5 seconds.
1 = Drift, leg falls by the end of the 5
second period but does not hit bed.
2 = Some effort against gravity, leg falls
to bed by 5 seconds, but has some effort
against gravity.
3 = No effort against gravity, leg falls to
bed
immediately.
4 = No movement.
9 = Amputation, joint fusion -explain:
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 12 of 29
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7.= Right Leg
8. = Left Leg
9. Limb Ataxia:
This item is aimed at finding evidence of a
unilateral cerebellar lesion. Test with eyes
open. In case of visual defect, ensure
testing is done in intact visual field. The
finger-nose-finger and heel-shin tests are
performed on both sides, and ataxia is
scored only if present out of proportion to
weakness. Ataxia is absent in the patient
who cannot understand or is hemiplegic.
Only in the case of amputation or joint
fusion may the item be scored “9”, and the
examiner must clearly write the explanation
for not scoring. In case of blindness, test
by touching nose from extended arm
position.
10. Sensory:
Sensation or grimace to pinprick when
tested, or withdrawal from noxious stimulus
in the obtunded or aphasic patient. Only
sensory loss attributed to stroke is scored
as abnormal and the examiner should test
as many body areas [arms (not hands),
legs, trunk, face] as needed to accurately
check for hemisensory loss. A score of 2,
“severe or total”, should only be given when
a severe or total loss of sensation can be
clearly demonstrated. Stuporous and
aphasic patients will therefore probably
score 1 or 0. The patient with brainstem
stroke who has bilateral loss of sensation is
scored 2. If the patient does not respond
and is quadriplegic, score 2. Patients in
coma (item 1a=3) are arbitrarily given a 2
on this item.
11. Best Language:
A great deal of information about
comprehension will be obtained during the
preceding sections of the examination. The
patient is asked to describe what is
happening in the attached picture, to name
the items on the attached list of sentences.
Comprehension is judged from responses
here as well as to all of the commands in
the preceding general neurological exam. If
visual loss interferes with the tests, ask the
patient to identify objects placed in the
hand, repeat, and produce speech. The
intubated patient should be asked to write.
The patient in coma (question 1a = 3) will
arbitrarily score 3 on this item. The
0 = Absent.
1 = Present in one limb.
2 = Present in two limbs.
0 = Normal; no sensory loss.
1 = Mild to moderate sensory loss; patient
feels pinprick is less sharp or is dull on
the affected side; or there is a loss of
superficial pain with pinprick but patient is
aware he/she is being touched.
2 = Severe to total sensory loss; patient is
not aware of being touched.
0 = No aphasia, normal.
1 = Mild to moderate aphasia; some
obvious loss of fluency or facility of
comprehension, without significant
limitation on ideas expressed or form of
expression. Reduction of speech and/or
comprehension, however, makes
conversation about provided material
difficult or impossible. For example, in
conversation about provided materials
examiner can identify picture or naming
card from patient’s response.
2 = Severe aphasia; all communication is
through fragmentary expression; great
need for inference, questioning, and
guessing by the listener. Range of
Stroke Thrombolysis Guideline Extended Age and Treatment Window
Page 13 of 29
examiner must choose a score in the
patient with stupor or limited cooperation
but a score of 3 should be used only if the
patient is mute and follows no one step
commands.
information that can be exchanged is
limited; listener carries burden of
communication. Examiner cannot identify
materials provided from patient response.
3 = Mute, global aphasia; no usable
speech or auditory comprehension.
12. Dysarthria:
If the patient is thought to be normal, an
adequate sample of speech must be
obtained by asking patient to read or repeat
words from the attached list. If the patient
has severe aphasia, the clarity of
articulation of spontaneous speech can be
rated. Only if the patient is intubated or has
other physical barrier to producing speech
may the item be scored “9", and the
examiner must clearly write an explanation
for not scoring. Do not tell the patient why
he/she is being tested.
13. Extinction and Inattention
(formerly Neglect)
Sufficient information to identify neglect
may be obtained during the prior testing. If
the patient has severe visual loss
preventing visual double simultaneous
stimulation, and the cutaneous stimuli are
normal, the score is normal. If the patient
has aphasia but does appear to attend to
both sides, the score is normal. The
presence of visual spatial neglect or
anosagnosia may also be taken as
evidence of neglect. Since neglect is
scored only if present, the item is never
untestable.
0 = Normal.
1 = Mild to moderate; patient slurs at least
some words and, at worst, can be
understood with some difficulty.
2 = Severe; patient’s speech is so slurred
as to be unintelligible in the absence of or
out of proportion to any dysphasia, or is
mute/anarthric.
9 = Intubated or other physical barrier explain:
0 = No abnormality.
1 = Visual, tactile, auditory, spatial, or
personal inattention or extinction to
bilateral
simultaneous stimulation in one of the
sensory modalities.
2 = Profound hemi-inattention or hemiinattention to more than one modality.
Does not recognize own hand or orients
to only one side of space.
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-----------
-----------
-----------
-----------
Total
Max
score 42
Total
Max
score 42
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Nursing Protocol
Nursing Care Following Thrombolysis for Stroke
1. Patient to be nursed in identified bed space that allows for continuous observation.
2. Oxygen, Suction, Cardiac Monitor, Sphygmomanometer, O2 Saturation machine should be
available at the bed side. Capillary blood glucose machine, Anaphylaxis box should be
easily accessible.
3. Initiate post administration thrombolysis care plan on arrival
4. Perform patient observations as indicated and record a baseline ECG
5. If there are any concerns, medical review is essential. Report, review, document and
increase frequency of observations accordingly.
6. Pyrexia > 37°C should be treated with PR or PO Paracetamol (1g 4-6 hourly. No more
than 4g in 24 hours)
7. If haemorrhage is suspected, report immediately and arrange for urgent medical
review. Send urgent FBC, clotting and group and save
8. If anaphylaxis is suspected (Tachypnoea, dyspnoea, tachycardia, swelling, rash) Stop
infusion and employ anaphylaxis protocol. Arrange for urgent medical review or
perform a crash call (2222) if required
9. Avoid catheterisation for 24 hours following thrombolysis infusion to minimise the risk of
trauma and bleeding. If essential, consult with medical team.
10. Do not insert naso gastric tubes for 24 hours post thrombolysis infusion to minimise the
risk of trauma and bleeding
11. IM injections should be avoided for 48 hours post thrombolysis infusion to minimise the
risk of excessive bruising
12. Avoid giving heparin / warfarin. Refer to medical staff before commencing any anti
coagulant or antiplatelet therapy (only given if CT at 24h shows no bleeding).
Stroke Thrombolysis Guideline Extended Age and Treatment Window
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Observations following administration of
thrombolysis for stroke
Manual BP, Pulse, Temperature, Respirations,
GCS and Oxygen Saturations (NEWS Score – Refer to local
Guidelines)
Every 15 minutes for 2 hours
Every 30 minutes for 6 hours
Hourly for 18 hours
Maintain BP < Systolic 180 / Diastolic 105
Temperature not to exceed 37°C.





Observe for signs of raised intracranial pressure or intracranial
bleeding
Unequal pupils
Sudden drop in GCS
Onset of drowsiness
Onset of nausea, vomiting (photophobia)
Rising BP and falling pulse
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Short NIHSS scoring sheet
This is master copy – patient packs
include this sheet which should be filed
in medical notes with completed
inclusion/exclusion checklist
National Institute for Health Stroke Scale (NIHSS)
REFER TO LAMINATED FULL GUIDANCE FOR SCORING
Score
Score
Date and Time
1a. LOC
Score 0-3
1b. LOC – Response to Questions
Score 0-2
1c. LOC – Response to Commands
Score 0-2
2. Best gaze
Score 0-2
3. Visual fields
Score 0-3
4. Facial palsy
Score 0-3
5. Right Arm motor
Score 0-4 or X if untestable
6. Left Arm motor
Score 0-4 or X if untestable
7. Right Leg motor
Score 0-4 or X if untestable
8. Left leg motor
Score 0-4 or X if untestable
9. Ataxia
Score 0-2 or X if untestable
10. Sensory
Score 0-2
11. Best language
Score 0-3
12. Dysarthria
Score 0-2 or X if untestable
13. Neglect/Inattention
Score 0-2
Total Score (0-42)
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Score
Score
Evidence for mechanical thrombectomy in acute ischemic stroke updated
November 2016 [1,7].
RCP NICE stroke guidelines (Oct 2016)




Patients with acute ischaemic stroke should be considered for
combination intravenous thrombolysis and intra-arterial clot extraction
(using stent retriever and/or aspiration techniques) if they have a
proximal intracranial large vessel occlusion causing a disabling
neurological deficit (National Institutes of Health Stroke Scale [NIHSS]
score of 6 or more) and the procedure can begin (arterial puncture)
within 5 hours of known onset.
Patients with acute ischaemic stroke and a contraindication to
intravenous thrombolysis but not to thrombectomy should be considered
for intra-arterial clot extraction (using stent retriever and/or aspiration
techniques) if they have a proximal intracranial large vessel occlusion
causing a disabling neurological deficit (National Institutes of Health
Stroke Scale[NIHSS] score of 6 or more) and the procedure can begin
(arterial puncture) within 5 hours of known onset.
Patients with acute ischaemic stroke causing a disabling neurological
deficit (a National Institutes of Health Stroke Scale [NIHSS] score of 6 or
more) may be considered for intraarterial clot extraction (using stent
retriever
and/or
aspiration
techniques,
with
priorintravenous
thrombolysis unless contraindicated) beyond an onset-to-arterial
puncture time of 5 hours if:
‒
the large artery occlusion is in the posterior circulation, in which
case treatment up to 24hours after onset may be appropriate;
‒
a favourable profile on salvageable brain tissue imaging has been
proven, in which casetreatment up to 12 hours after onset may be
appropriate.
Hyperacute stroke services providing endovascular therapy should
participate in national stroke audit to enable comparison of the clinical
and organisational quality of their services with national data, and use
the findings to plan and deliver service improvements.
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Summary of Meta-analysis of 5 trials summary:
BACKGROUND
In 2015, five randomised trials showed efficacy of endovascular thrombectomy over standard
medical care in patients with acute ischaemic stroke caused by occlusion of arteries of the
proximal anterior circulation. In this meta-analysis the trial investigators, aimed to pool
individual patient data from these trials to address remaining questions about whether the
therapy is efficacious across the diverse populations included.
METHODS
We formed the HERMES collaboration to pool patient-level data from five trials (MR CLEAN,
ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) done between December, 2010, and
December, 2014. In these trials, patients with acute ischaemic stroke caused by occlusion of
the proximal anterior artery circulation were randomly assigned to receive either endovascular
thrombectomy within 12 h of symptom onset or standard care (control), with a primary
outcome of reduced disability on the modified Rankin Scale (mRS) at 90 days. By direct access
to the study databases, we extracted individual patient data that we used to assess the
primary outcome of reduced disability on mRS at 90 days in the pooled population and
examine heterogeneity of this treatment effect across prespecified subgroups. To account for
between-trial variance we used mixed-effects modelling with random effects for parameters of
interest. We then used mixed-effects ordinal logistic regression models to calculate common
odds ratios (cOR) for the primary outcome in the whole population (shift analysis) and in
subgroups after adjustment for age, sex, baseline stroke severity (National Institutes of Health
Stroke Scale score), site of occlusion (internal carotid artery vs M1 segment of middle cerebral
artery vs M2 segment of middle cerebral artery), intravenous alteplase (yes vs no), baseline
Alberta Stroke Program Early CT score, and time from stroke onset to randomisation.
FINDINGS
We analysed individual data for 1287 patients (634 assigned to endovascular thrombectomy,
653 assigned to control). Endovascular thrombectomy led to significantly reduced disability at
90 days compared with control (adjusted cOR 2.49, 95% CI 1.76-3.53; p<0.0001). The
number needed to treat with endovascular thrombectomy to reduce disability by at least one
level on mRS for one patient was 2.6. Subgroup analysis of the primary endpoint showed no
heterogeneity of treatment effect across prespecified subgroups for reduced disability
(pinteraction=0.43). Effect sizes favouring endovascular thrombectomy over control were
present in several strata of special interest, including in patients aged 80 years or older (cOR
3.68, 95% CI 1.95-6.92), those randomised more than 300 min after symptom onset (1.76,
1.05-2.97), and those not eligible for intravenous alteplase (2.43, 1.30-4.55). Mortality at 90
days and risk of parenchymal haematoma and symptomatic intracranial haemorrhage did not
differ between populations.
INTERPRETATION
Endovascular thrombectomy is of benefit to most patients with acute ischaemic stroke caused
by occlusion of the proximal anterior circulation, irrespective of patient characteristics or
geographical location. These findings will have global implications on structuring systems of
care to provide timely treatment to patients with acute ischaemic stroke due to large vessel
occlusion.
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Education
Training for stroke thrombolysis is available as an e-learning package from the
RCHT electronic learning management website ESR. The course title is 156
Thrombolysis in Acute Stroke Patients Online and Employee Support is
available on ext 5148.
For NIHSS training please visit the website:
https://secure.trainingcampus.net/uas/modules/trees/windex.aspx?rx=nihssenglish.trainingcampus.net and enter your NHS email for account registration.
NIHSS training needs to be renewed every 3 years and it is the responsibility
of the individual clinician to ensure training is in date.
The stroke team provide face to face training sessions if required. Please
contact Dr K Adie, consultant stroke physician [email protected]
References
1. NICE Guidance TA 122 - Alteplase for the treatment of acute ischaemic stroke
Intercollegiate Stroke Working Party.
2. National Clinical Guidelines for Stroke. Royal College of Physicians. 6th edition.
2016.
3. Berkhemer OA et al. Mr CLEAN Investigators. A randomized trial of intraarterial
treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11
4. Goyal M et al, ESCAPE Trial Investigators. Randomized assessment of rapid
endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019.
5. Saver JL et al. SWIFT PRIME Investigators. Stent-retriever thrombectomy after
intravenous t-PA vs. t-PA alone in stroke. N Engl J Med.
2015;372(24):2285
6. Campbell BC et al. Endovascular therapy for ischemic stroke with
perfusion-imaging selection. EXTEND-IA Investigators. N Engl J Med.
2015;372(11):1009.
7. Jovin et al. Thrombectomy within 8 hours after symptom onset in
ischemic stroke. REVASCAT Trial Investigators. N Engl J Med.
2015;372(24):2296.
8. Goyal et al. Endovascular thrombectomy after large-vessel ischaemic
stroke: a meta-analysis of individual patient data from five randomised
trials. HERMES collaborators. Lancet. 2016;387(10029):1723.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
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3. Monitoring compliance and effectiveness
Element to be
monitored
Lead
Outcome of thrombolysis for individual patients
Tool
Sentinel Stroke National Audit Programme (SSNAP) from the Royal
College of Physicians
Frequency
Each thrombolysed patients details and outcomes are entered on
to SSNAP
Reporting
arrangements
Dr Adie reports outcome locally to the eldercare governance and
Emergency Department meeting monthly
SSNAP data is collected as part of the Trust Clinical Audit &
Outcomes Programme on an ongoing basis
SSNAP data is reported and published nationally and monitored by
the Clinical Commissioning Group
Dr Adie, Dr Harrington
Dr Katja Adie/ Dr Frances Harrington
Acting on
recommendations
and Lead(s)
Change in
Required changes to practice will be identified and actioned within
practice and
six months. Dr Adie and Dr Harrington as lead members of the
lessons to be
team will take each change forward where appropriate.
shared
Stroke Thrombolysis Guideline Extended Age and Treatment Window
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4. Equality and Diversity
4.1 This document complies with the Royal Cornwall Hospitals NHS Trust service
Equality and Diversity statement.
4.2 Equality Impact Assessment
The Initial Equality Impact Assessment Screening Form is at Appendix 2.
Appendix 1. Governance Information
Document Title
Stroke Thrombolysis Guideline (Emergency
Department run service)
Date Issued/Approved:
11/11/2016
Date Valid From:
11/11/2016
Date Valid To:
11/11/2019
Directorate / Department responsible
(author/owner):
Dr Katja Adie and Frances Harrington,
Consultant Physician, Eldercare RCHT
Contact details:
01872 252447/ 07717714009
Brief summary of contents
Guideline for the administration of
thrombolysis for acute ischaemic stroke
Suggested Keywords:
Stroke, Thrombolysis, Alteplase
RCHT

Target Audience
PCH
CFT
KCCG
Executive Director responsible for
Policy:
Malcolm Stewart
Date revised:
11/11/2016
This document replaces (exact title of
previous version):
Clinical guideline to deliver safe and
effective thrombolysis for acute ischaemic
stroke using robust evidence based clinical
criteria
Approval route (names of
committees)/consultation:
Acute Stroke Group, SERCO, SWAST
Divisional Manager confirming
approval processes
Dr Gaby Lockwood
Name and Post Title of additional
signatories
Name and Signature of
Divisional/Directorate Governance
Not Required
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Page 26 of 29
Lead confirming approval by specialty
and divisional management meetings
Name:
Publication Location (refer to Policy
on Policies – Approvals and
Ratification):
Internet & Intranet
Document Library Folder/Sub Folder
Clinical / Neurology and Stroke
Links to key external standards
Related Documents:
Training Need Identified?
 Intranet Only
NICE Guidance TA122 - Alteplase for the
treatment of acute ischaemic stroke
National Stroke Guidelines 2016
Advanced Stroke Management Pathway
Acute Stroke Management
Stroke and TIA Multidisciplinary Care
Pathway
Secondary Prevention after Stroke or TIA
Yes. Learning and Development
department have been informed.
Version Control Table
July 2008
Versi
Summary of Changes
on
No Initial Issue
V1.0
Dr F Harrington
Dec 2010
V2.0 Amendment to 24/7 service
Dr F Harrington
3/9/12
V3.0 Extended age and treatment window
Dr F Harrington
21/1/14
V4.0
Date
Changes Made by
(Name and Job Title)
Change of service provision from Eldercare to
Dr F Harrington
Emergency Department team
2/10/2015
V5.0 Availability of intraarterial treatment
Dr F Harrington
Dr K Adie
A James
11/11/2016
V6.0 Updated Evidence and change in pathway
Dr K Adie
Dr F Harrington
All or part of this document can be released under the Freedom of Information
Act 2000
This document is to be retained for 10 years from the date of expiry.
This document is only valid on the day of printing
Controlled Document
This document has been created following the Royal Cornwall Hospitals NHS Trust
Policy on Document Production. It should not be altered in any way without the
express permission of the author or their Line Manager.
Stroke Thrombolysis Guideline Extended Age and Treatment Window
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Appendix 2. Initial Equality Impact Assessment Form
Name of service, strategy, policy or project (hereafter referred to as policy) to be
assessed: Stroke Thrombolysis Guideline Extended Age and Treatment Window
Directorate and service area:
Is this a new or existing Procedure? existing
Name of individual completing
Telephone: 01872 253290
assessment: Dr F Harrington
1. Policy Aim*
To safely administer thrombolytic agent to acute ischaemic
stroke patients using updated, clearly defined criteria
2. Policy Objectives*
Safe administration of emergency drug therapy
Clear advice and guidance for staff involved in the
administration of emergency treatment and aftercare of
patients who have undergone thrombolysis for stroke
3. Policy – intended
As above
Outcomes*
4. How will you measure Patient response to treatment
the outcome?
Audit – ongoing local and RCP National Sentinel Stroke
Audit
Inclusion in international SITS-MOST register (Safe
implementation of thrombolysis in stroke)
5. Who is intended to
Patients: through the promotion of safe, effective, evidence
benefit from the Policy?
based practice
6a. Is consultation
required with the
workforce, equality
groups, local interest
groups etc. around this
policy?
Yes
b. If yes, have these
groups been consulted?
Yes
c. Please list any groups
who have been consulted
about this procedure.
Acute Stroke Group, SERCO, SWAST
7. The Impact
Please complete the following table.
Are there concerns that the policy could have differential impact on:
Equality Strands:
Age
Sex (male, female, trans-
Yes
No

Rationale for Assessment / Existing Evidence
Removal of upper age limit for stroke thrombolysis based
on recent randomised controlled trials

gender / gender
reassignment)
Race / Ethnic
communities /groups

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Disability -

Learning disability, physical
disability, sensory impairment
and mental health problems
Religion /
other beliefs

Marriage and civil
partnership

Pregnancy and maternity

Sexual Orientation,

Bisexual, Gay, heterosexual,
Lesbian
You will need to continue to a full Equality Impact Assessment if the following have been
highlighted:
 You have ticked “Yes” in any column above and
 No consultation or evidence of there being consultation- this excludes any policies
which have been identified as not requiring consultation. or
 Major service redesign or development
No
8. Please indicate if a full equality analysis is recommended.
Yes

9. If you are not recommending a Full Impact assessment please explain why.
Signature of policy developer / lead manager / director
Names and signatures of
members carrying out the
Screening Assessment
Date of completion and submission
1.
2.
Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead,
c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa,
Truro, Cornwall, TR1 3HD
A summary of the results will be published on the Trust’s web site.
Signed _______________
Date ________________
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