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Help maintain quality care
in patients with central lines
Types of CVADs
• Central venous access devices (CVADs), also known as central venous catheters or
Nontunneled catheters2,5
• More than 7 million CVADs are implanted every year in patients in the United States
• Also called subclavian, percutaneous, or short-term catheters
• Typically used for days or weeks for all types of IV therapy, to draw blood, and to
Access to central venous circulation
• May be placed bedside or, if necessary, in an emergency setting, without sedation
• The tip of a CVAD is generally placed in the lower third of the superior vena cava (SVC) near its
Peripherally inserted central catheters (PICCs)5
central lines, have become a mainstay for patients requiring intravenous (IV) administration
of medications and other fluids
1,2
junction with the right atrium.2,3 Because the blood-flow rate here is approximately 2 liters per minute,
infusates are rapidly hemodiluted and distributed in the central venous system4
catheter management
The role of central venous access devices
monitor central venous pressure
• Can be used for a variety of IV therapies, as well as for obtaining blood samples in
a variety of care settings from diverse patient populations
• May be placed bedside or in an outpatient setting
CVAD insertion and tip sites3,5
Tunneled catheters2,5
• Designed for long-term use and frequent venous access
• Provide more reliable IV access for extended courses of antibiotics, chemotherapy,
and parenteral nutrition
InTernAl juGulAr
• Surgically inserted
SubClAVIAn
SuperIor VenA CAVA
( TIp loCATIon )
CephAlIC
brAChIAl
bASIlIC
InFerIor VenA CAVA
(AlTernATe TIp loCATIon)
Implanted ports2,5
• Consist of 2 attached parts: the catheter and portal body with reservoir
• Long-term dwell capacity, requiring little maintenance when not in use
• Useful for cyclically infused therapies, such as chemotherapy. Blood draws
may also be done through the port
• Surgically inserted
FemorAl
2
3
Administration, cont’d
One in 4 catheters may become occluded6
7
Nonthrombotic
catheter occlusions
Catheter occlusion is the most common noninfectious complication
in the long-term use of CVADs7
INSTILL 8the appropriate dose of Cathflo into the occluded catheter
Mechanical occlusions
• Occlusions may occur in up to 25% of CVADs
6
— May occur soon after insertion of a device or develop at any time during the course of IV therapy 8
Causes of catheter occlusions
• About 58% of catheter occlusions are thrombotic
• Thrombotic occlusions result from the formation
of a thrombus within, surrounding, or at the tip
of the catheter 6,8
• About 42% of catheter occlusions are due
to nonthrombotic causes, including
precipitates, malpositioning, mechanical
obstructions, and other factors6,8
using an appropriately sized syringe (see dosing chart below).
• Mechanical occlusions may result from malposition during insertion and use, or catheter migration
8
• Factors influencing the incidence of malposition include an increase in intrathoracic pressure from
coughing, sneezing, or vomiting;
arm movements;
flushing
of the catheter;
and
After 30 minutes
of DWELL forceful
time, assess
the catheter
function
by thrombus
attemptingformation
30
8
minutes
Precipitates
30
9 minutes
6
to aspirate blood. If the catheter is functional, go to step 10; if not functional,
go to step 9.
a result of
drug crystallization,
incompatibilities,
or time by
catheter
function after drug-drug
a total of 120
minutes of dwell
• Precipitates can form asASSESS
58%
thrombotic
drug-solution incompatibilities
attempting to aspirate blood. If catheter is functional, go to step 10.
If catheter is still occluded, a second dose of equal amount may be
Drug120
precipitates in the catheter may occur in conjunction with thrombus formation and should always
instilled. Repeat steps 1 through 8.
minutes
120
be considered
during assessment of an occlusion, since this may have implications for how the occlusion
minutes
10
should
be managed
If catheter function has been restored, ASPIRATE 4 mL to 5 mL of blood in
patients ≥10 kg or 3 mL in patients <10 kg to remove Cathflo and residual
8
clot. Then gently irrigate the catheter with 0.9% Sodium Chloride, USP.
Lipid residue
Any unused solution should be discarded.
Lipid residue can accumulate in central venous catheters, often following the administration of lipid-containing,
three-in-one total parenteral nutrition admixtures
or drugs with oleaginous vehicles
17
•
42%
nonthrombotic
•
Dosing with Cathflo 2 mg
Patient weight
Cathflo dose
30 kg (66 lb)
2 mg in 2 mL
Salvaging catheters with nonthrombotic occlusions8
• In many instances, mechanical problems, such as kinked tubing or clogged in-line filters, can be identified
and corrected
110% of the internal lumen volume of
<30 kg (66 lb)
CVAD, not
to exceed
2 mg
in 2 positioning,
mL
— Possible interventions to reposition
catheters
include
patient
rapid flushing of the catheter
Note:
Store
lyophilized
Cathflo
at
refrigerated
temperature
(2˚C-8˚C/36˚F-46˚F).
Cathflo
should
be
guidewire catheter exchange, fluoroscopic catheter guidance, or partial catheter withdrawal
reconstituted immediately before use. The solution may be used within 8 hours if stored at 2˚C to 30˚C
(36˚F-86˚F). No other medication should be added to solutions containing Cathflo.
• Catheters occluded by calcium-phosphate precipitates can be treated with 0.1 N hydrochloric acid
function(1ismEq/mL)
not restored
at 120
after known
1 dose to
of Cathflo,
doseenvironment
may be instilled
bicarbonate
is used
forminutes
substances
dissolve a
in second
an alkaline
• If catheter
• Sodium
• Studies have not been performed with administration of total doses greater than 4 mg (two 2-mg doses)
• Lipid occlusions have been treated with ethanol (70%) or sodium hydroxide (0.1 mmol/mL)
• The use of incompatible drugs or solutions should be avoided
References: 1. Brown M. The impact of safety product use on catheter-related infections. J Infus Nurs. 2004;27(4):245-250. 2. Richardson D. Vascular access nursing: standards of care, and
strategies in the prevention of infection: a primer on central venous catheters (part 2 of a 3-part series). JAVA. 2007;12(1):19-27. 3. Infusion Nurses Society. Infusion therapy standards of practice.
J Infus Nurs. 2016;39(suppl 1):S1-S159. 4. Mohiaddin RH, Wann SL, Underwood R, Firmin DN, Rees S, Longmore DB. Vena caval flow: assessment with cine MR velocity mapping. Radiology.
1990;177(2):537-541. 5. Camp-Sorrell D, ed. Access Device Guidelines: Recommendations for Nursing Practice and Education. 3rd ed. Pittsburgh, PA: Oncology Nursing Society; 2011:1-170.
6. Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? J Parenter Enteral Nutr. 1995;19(1):75-79. 7. McKnight S. Nurse’s
guide to understanding and treating thrombotic occlusion of central venous access devices. Medsurg Nurs. 2004;13(6):377-382. 8. National Institutes of Health. Management of central venous
catheter occlusions. Pharm Update. 1999 Nov/Dec:1-4. 9. Ryder M. The role of biofilm in vascular catheter-related infections. N Dev Vasc Dis. 2001;2:15-25. 10. Hadaway LC. Reopen
the pipeline for IV therapy. Nursing. 2005;35(8):54-61. 11. Haire WD, Herbst SF. Consensus conference on the use of alteplase (t-PA) for the management of thrombotic catheter
dysfunction. J Vasc Access Devices. Summer 2000:1-8. 12. Wingerter L. Vascular access device thrombosis. Clin J Oncol Nurs. 2003;7(3):345-348. 13. Cummings-Winfield C, MushaniKanji T. Restoring patency to central venous access devices. Clin J Oncol Nurs. 2008;12(6):925-934. 14. Kokotis K. Cost containment and infusion services. J Infus Nurs. 2005;28(suppl
3):S22-S32. 15. Harpel J. Best practices for vascular resource teams. J Infus Nurs. 2013;36(1):46-50. 16. Blaney M, Shen V, Kerner JA, et al; for CAPS Investigators. Alteplase for the
treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (the Cathflo Activase Pediatric Study). J Vasc Interv Radiol.
2006;17(11 Pt 1):1745-1751. 17. Cathflo Prescribing Information. Genentech USA, Inc. 18. Kaler W, Chinn R. Successful disinfection of needleless access ports: a matter
of time and friction. JAVA. 2007;12(3):140-142.
4
17
1
5
Thrombotic catheter occlusions
Catheter occlusions can be partial or complete7
When introduced into the body, all catheters begin to accumulate fibrin. This is the body’s natural
attempt to protect itself against a foreign body. The fibrin starts to form a layer around the outside
of the catheter within minutes of insertion, beginning at either the line entry site or where the tip
contacts the vein.9,10
• Partial occlusion: ability to infuse but not withdraw fluids, or the presence of sluggish flow*
• Complete occlusion: inability to infuse or aspirate
Partial occlusion
Complete occlusion
Intraluminal thrombus11
• Occurs when blood refluxes inside the catheter lumen
• Common causes of reflux include patient coughing, inadequate
(B)
flushing after blood draws or after checking for blood return, or
improper use of flush syringes
(A)
Intraluminal thrombus
Fibrin tail, or flap11
• Extends from the catheter tip but is drawn inward, blocking the
© Penny Offer, CRNI
© Penny Offer, CRNI
Recovered triple-lumen catheter
showing a fibrin tail (A).
Fibrin sheath encases a
completely occluded catheter (B).
opening of the catheter lumen on aspiration attempts
• Results in an ability to infuse fluids but an inability to withdraw blood
Mural thrombus10-12
Aspirating for a positive blood return may reveal a partial occlusion
Fibrin tail
Fibrin tail allowing infusion
Beginning to flap back with
start of withdrawal
Blocking aspiration
of the catheter
© Penny Offer, CRNI
© Penny Offer, CRNI
© Penny Offer, CRNI
• Forms where the catheter touches or “rubs” the vein wall
• Common sites are the entry site, anywhere along the catheter path,
and the catheter tip
Fibrin sheath10,11
•
Forms when fibrin adheres to the external catheter surface,
often beginning at the entry site, and may encase all or
part of the catheter like a sock
Mural thrombus
• May completely cover the opening of the catheter tip
Fibrin sheath
Flushing the line is not enough—you must be able to withdraw blood to
rule out a partial occlusion before administering critical therapies.3
*One quantitative measure for sluggish flow is a blood return of less than 3 mL in 3 seconds,
as recommended by the Oncology Nursing Advisory Board.13
6
7
Catheters deliver life-sustaining therapies
Why is it important to ensure central line patency?
Catheters can be used either short or long term for the infusion of 2
• An occluded line may compromise patient care by
7,14
— Disrupting therapies or delaying procedures
— Interrupting administration of medications and solutions
• Parenteral nutrition
• Chemotherapy or other vesicant or
• Replacement of an occluded line may
7
— Increase patient discomfort and trauma
— Increase cost of care
irritating solutions
• Blood and blood products
• Antibiotics
Satisfaction with infusion care is linked to a hospital’s
patient satisfaction scores.15
• Medication/solutions in patients with
limited peripheral access
• Therapy that is ongoing or continued
at home
CVADs are also useful when frequent blood tests are required, reducing the
need for repeated venipuncture.2
Documentation of CVAD functionality assessment
is recommended by key societies, and should include3,5
• Device patency
• Absence of signs and symptoms of complications
• Lack of resistance when flushing
• Presence of a blood return upon aspiration
“Documentation reflects the continuity, quality, and safety of care.” 3
—INS Infusion Therapy Standards of Practice, 2016,
page S28, standard 10.4
INS=Infusion Nurses Society.
8
9
Recognizing signs of CVAD occlusion
“Central vascular access devices (CVADs) [should be] regularly assessed
for patency and proper function as defined by the ability to flush the
catheter without resistance and the ability to yield a blood return.” 3
—INS Infusion Therapy Standards of Practice, 2016,
page S104, standard 48.1
With a blood flow through the SVC of approximately 2 liters per minute,
a free-flowing blood return should be readily achievable.4
Superior vena cava
Lack of blood return or a sluggish flow may indicate
a catheter occlusion or a malpositioned tip, and further
assessment of the line will be necessary.3
Signs of a CVAD occlusion include3
“Vascular access devices (VADs) [should be] flushed and aspirated
for a blood return prior to each infusion to assess catheter function
and prevent complications.” 3
—INS Infusion Therapy Standards of Practice, 2016,
page S77, standard 40 .1
Prior to the administration of any medications or solutions,
the nurse should always3
• Aspirate for a positive blood return
• Check for other indications of an occlusion
• Attempt to flush to determine resistance, flushing with
an adequate volume of saline or appropriate solution
• Inability to withdraw blood
• Palpate the insertion site to determine tenderness
• Assess the patient for any pain or discomfort
or sluggish blood return
• Sluggish flow
• Inability to flush or infuse
Recommended routine assessment of
catheter patency
Blood flow
~2 L/min
through the CVAD
• Frequent occlusion alarms
on electronic infusion device
• Infiltration/extravasation or
swelling/leaking at the infusion site
Catheter tip
CVAD occlusions should not be left
untreated because another lumen is patent3
© Adam Questell, A KYU Design
“Catheter salvage is preferred over catheter removal for management
of CVAD occlusions.” 3
—INS Infusion Therapy Standards of Practice, 2016,
page S104, standard 48.3
10
Institutions should adopt standardized procedures to manage thrombotic
occlusions. This includes educational and skill-development needs of
team members, followed by the design of appropriate educational
materials and training.13
—Clinical Journal of Oncology Nursing, 2008
Volume 12, Issue 6, page 931
11
Recommended algorithm for assessing and treating
occluded catheters7
Sluggish
g
flow or inability to withdraw blood
or infuse fluid
d th
through
h th
the catheter
Flow
restored
Check for presence of
nonthrombotic
b ti obstruction
b
• Cathflo, a recombinant form of t-PA, is the only lytic that is FDA approved for the restoration of function
Obstruction
remains
to CVADs16
Suspect thrombotic
occlusion
l
Function
restored
Insti Cathflo® Activase
Instill
vase®
(alteplase)
l
) 2 mg
Function
restored
Obstruction
remains
Cathflo—a fibrin-specific* MOA17
Obstruction
remains
Repeat Cathflo 2 mg
Yes
Cathflo Activase (alteplase) plays a
key role in helping to restore function
to catheters with thrombotic occlusions
• The fibrin-specific mechanism of action (MOA) of Cathflo addresses the root cause of thrombotic occlusions
• Cathflo binds to fibrin in the thrombus, converting entrapped plasminogen to plasmin, initiating local fibrinolysis
Obstruction
remains
Suspect nonthrombotic
occlusion
l
Administer appropriate
solvents per h
hospital
it protocol
No
Flow
restored
2
Activation
Consult with medical team to consider alternative
etiologies and additionall management strategies
Adapted from McKnight S.
• Cathflo is recommended for the treatment of partial or complete thrombotic occlusions, after ruling out
nonthrombotic obstruction, by clinical practice guidelines of the INS, the Association for Vascular Access,
the Oncology Nursing Society, and other treatment algorithms3,5,7,11,13
1
A
t-P
Plasmin
m
Plas
Thrombus
Dissolves
fibrin
3 Fibrin
degradation
products
Fibrin threads
1 Recombinant t-PA (alteplase) binds to fibrin in thrombus 2 converts entrapped
plasminogen to plasmin that 3 initiates local fibrinolysis.
product information
Indication
Cathflo® Activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by
the ability to withdraw blood.
Important Safety Information
Contraindications
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component
of the formulation.
Precautions
General
Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter
malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen).
Bleeding
The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.
Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur,
treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.
Infections
Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.
Adverse Reactions
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding,
and venous thrombosis.
t-PA
en
inog
*The clinical significance of fibrin specificity is unknown.
Cathflo pharmacokinetics
• Cathflo 2 mg does not reach pharmacologic levels in systemic circulation
17
Please see accompanying full Prescribing Information for additional Important Safety Information.
12
13
Cathflo® Activase® (alteplase) may restore
catheter function
Cathflo safety profile in adult and
pediatric patients
• In the pivotal trials COOL-1 and COOL-2, the efficacy of Cathflo was evaluated
Cathflo has a safety profile studied in both adult and pediatric patients as young
as 2 weeks of age.16,17
in 1122 primarily adult patients17
88%
75%
72%
74%
Cumulative efficacy
In COOL-1, Cathflo restored function to 88% (112/127) of central lines after up
to 2 doses using a 120-minute dwell time for each in catheters with occlusions
present for up to 24 hours.
In COOL-1 and COOL-2, Cathflo restored function to 68% (796/1043) of central
lines after 1 dose and 88% (902/1043) of central lines after 2 doses in catheters
with occlusions present for less than 14 days.
First-dose efficacy
In COOL-2, Cathflo restored function after 1 dose in 75% (747/995) of central
lines after up to 120 minutes of dwell time in catheters with occlusions present
for any duration.
Occlusions >14 days efficacy
In COOL-2, Cathflo restored function to 57% (30/53) of central lines after 1 dose
and 72% (38/53) of central lines after 2 doses in catheters with occlusions
present for longer than 14 days.
Maintained patency
In a subset of patients (n=346) who had a successful treatment outcome,
74% (256/346) of central lines maintained patency up to 30 days after
treatment with Cathflo.
COOL=Cardiovascular Thrombolytic to Open Occluded Lines.
COOL-1 was a double-blind, randomized, placebo-controlled study of 150 patients to evaluate the efficacy of
Cathflo 2 mg/2 mL, in up to 2 doses, with function assessed at 120 minutes.
COOL-2 was a phase III, single-arm, open-label, multicenter study of 995 patients to evaluate the safety of serial
administration of up to 2 doses of Cathflo. Secondary objectives included assessing success rates at 30 minutes
and 120 minutes.
• In the pivotal trials COOL-1 and COOL-2, the safety profile of Cathflo was evaluated in 1122
primarily adult patients17
• CAPS evaluated the safety profile of Cathflo in 310 pediatric patients. The youngest patient
in the study was 2 weeks old16,17
COOL-1 and COOL-2 (N=1122):
Serious adverse events17
Event
CAPS (N=310):
Serious adverse events16
(%)
Event
(%)
Sepsis
0.4%
Catheter-related complications
1.3%*
Major hemorrhage
0.4%
Sepsis
1.0%
Gastrointestinal bleeding
0.3%
Fever
Venous thrombosis
0.3%
Intracranial hemorrhage
0.0%
Intracranial hemorrhage
0.0%
Major hemorrhage
0.0%
Embolic event
0.0%
Thrombosis
0.0%
Embolic event
0.0%
<1.0%
Adapted
Blaney
M, et rupture
al.
*At least from
one due
to catheter
*At least 1 due to catheter rupture.
CAPS=Cathflo Activase Pediatric Study.
CAPS was an open-label, single-arm trial in 310 patients between the ages of 2 weeks and 17 years to evaluate the safety of Cathflo.
Secondary objectives included assessing restoration rates at 30 minutes and 120 minutes, and serious adverse events within 48 hours.16,17
• No reports of intracranial hemorrhage or embolic events with Cathflo in clinical trials, including infants
as young as 2 weeks of age16,17
The instillation of alteplase 2 mg (Cathflo Activase) is safe and
effective in restoring catheter patency in patients.3
— INS Infusion Therapy Standards of Practice, 2016,
page S105, standard 48, practice criterion G
Please see Indication and Important Safety Information on back cover.
Please also see accompanying full Prescribing Information.
14
15
Reconstitution, dosing, and administration of
One
in 4®catheters
become occluded6
Cathflo
Activase® may
(alteplase)
Administration, cont’d
7
INSTILL the appropriate dose of Cathflo into the occluded catheter
Cathflo is occlusion
available in is
a single-use,
vial. noninfectious complication
Catheter
the most 2-mg
common
7
inPreparation
the long-term
use of CVADs
17
of solution
17
WASHING
hands
using
aseptic
technique, reconstitute Cathflo to a final
Occlusions
may occur
in up
to 25%
of CVADs
•After
6
using an appropriately sized syringe (see dosing chart below).
8
concentration of 2 mg/2 mL:
— May occur soon after insertion of a device or develop at any time during the course of IV therapy 8
After 30 minutes of DWELL time, assess the catheter function by attempting
to aspirate blood. If the catheter is functional, go to step 10; if not functional,
go to step 9.
1
Causes of catheter occlusions
Aseptically WITHDRAW 2.2 mL of Sterile Water for Injection, USP (diluent
6
About 58% of catheter is
occlusions
are thrombotic
not provided).
Do not use Bacteriostatic Water for Injection, USP.
9
•
• 2Thrombotic occlusions result from the formation
ASSESS catheter function after a total of 120 minutes of dwell time by
of a thrombus within, surrounding, or at the tip
of the catheter 6,8
INJECT the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo vial,
58%
42%
to nonthrombotic causes, including
thrombotic
3precipitates, malpositioning, mechanical
6,8
nonthrombotic
obstructions, and otherMix
factors
by gently SWIRLING until the contents are completely dissolved.
Complete dissolution should occur within 3 minutes. DO NOT SHAKE.
The reconstituted preparation results in a colorless to pale yellow
transparent solution at a pH of approximately 7.3.
After WASHING hands and applying gloves:
4
120
120
minutes
minutes
the diluent stream into the powder. Slight foaming is not unusual;
occlusions are due
• About 42% of catheter directing
let the vial stand undisturbed to allow large bubbles to dissipate.
Administration17,18
30
30
minutes
minutes
10
If catheter function has been restored, ASPIRATE 4 mL to 5 mL of blood in
patients ≥10 kg or 3 mL in patients <10 kg to remove Cathflo and residual
clot. Then gently irrigate the catheter with 0.9% Sodium Chloride, USP.
Any unused solution should be discarded.
Dosing with Cathflo 2 mg17
Patient weight
Cathflo dose
30 kg (66 lb)
2 mg in 2 mL
<30 kg (66 lb)
INSPECT the product prior to administration for foreign matter and
discoloration. Solution should be inspected immediately before use.
attempting to aspirate blood. If catheter is functional, go to step 10.
If catheter is still occluded, a second dose of equal amount may be
instilled. Repeat steps 1 through 8.
110% of the internal lumen volume of
CVAD, not to exceed 2 mg in 2 mL
Note: Store lyophilized Cathflo at refrigerated temperature (2˚C-8˚C/36˚F-46˚F). Cathflo should be
reconstituted immediately before use. The solution may be used within 8 hours if stored at 2˚C to 30˚C
(36˚F-86˚F). No other medication should be added to solutions containing Cathflo.
• If catheter function is not restored at 120 minutes after 1 dose of Cathflo, a second dose may be instilled
• Studies have not been performed with administration of total doses greater than 4 mg (two 2-mg doses)
5
WITHDRAW 2 mL (2 mg) of reconstituted solution from the vial.
6
SCRUB the hub. Apply vigorous friction to the hubs for 15 to 30 seconds.
References: 1. Brown M. The impact of safety product use on catheter-related infections. J Infus Nurs. 2004;27(4):245-250. 2. Richardson D. Vascular access nursing: standards of care, and
strategies in the prevention of infection: a primer on central venous catheters (part 2 of a 3-part series). JAVA. 2007;12(1):19-27. 3. Infusion Nurses Society. Infusion therapy standards of practice.
J Infus Nurs. 2016;39(suppl 1):S1-S159. 4. Mohiaddin RH, Wann SL, Underwood R, Firmin DN, Rees S, Longmore DB. Vena caval flow: assessment with cine MR velocity mapping. Radiology.
1990;177(2):537-541. 5. Camp-Sorrell D, ed. Access Device Guidelines: Recommendations for Nursing Practice and Education. 3rd ed. Pittsburgh, PA: Oncology Nursing Society; 2011:1-170.
6. Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? J Parenter Enteral Nutr. 1995;19(1):75-79. 7. McKnight S. Nurse’s
guide to understanding and treating thrombotic occlusion of central venous access devices. Medsurg Nurs. 2004;13(6):377-382. 8. National Institutes of Health. Management of central venous
catheter occlusions. Pharm Update. 1999 Nov/Dec:1-4. 9. Ryder M. The role of biofilm in vascular catheter-related infections. N Dev Vasc Dis. 2001;2:15-25. 10. Hadaway LC. Reopen
the pipeline for IV therapy. Nursing. 2005;35(8):54-61. 11. Haire WD, Herbst SF. Consensus conference on the use of alteplase (t-PA) for the management of thrombotic catheter
dysfunction. J Vasc Access Devices. Summer 2000:1-8. 12. Wingerter L. Vascular access device thrombosis. Clin J Oncol Nurs. 2003;7(3):345-348. 13. Cummings-Winfield C, MushaniKanji T. Restoring patency to central venous access devices. Clin J Oncol Nurs. 2008;12(6):925-934. 14. Kokotis K. Cost containment and infusion services. J Infus Nurs. 2005;28(suppl
3):S22-S32. 15. Harpel J. Best practices for vascular resource teams. J Infus Nurs. 2013;36(1):46-50. 16. Blaney M, Shen V, Kerner JA, et al; for CAPS Investigators. Alteplase for the
treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (the Cathflo Activase Pediatric Study). J Vasc Interv Radiol.
2006;17(11 Pt 1):1745-1751. 17. Cathflo Prescribing Information. Genentech USA, Inc. 18. Kaler W, Chinn R. Successful disinfection of needleless access ports: a matter
of time and friction. JAVA. 2007;12(3):140-142.
Please see Indication and Important Safety Information on back cover.
Please also see accompanying full Prescribing Information.
16
4
17
1
Don’t let sluggish flow disrupt therapy
Take charge with Cathflo Activase (alteplase)
and help restore central line function
• Is there routine assessment of CVAD patency at your hospital?
your Genentech representative about resources to help you implement CVAD education and
• Ask
skill development
Indication
Cathflo Activase (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the
ability to withdraw blood.
Important Safety Information
Contraindications
Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component
of the formulation.
Precautions
General
Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter
malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen).
Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter.
Bleeding
The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase
has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics.
Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard.
Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment
with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.
Infections
Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Using
Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation.
Adverse Reactions
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding,
and venous thrombosis.
Please see full Prescribing Information for additional Important Safety Information.
To learn more about the management of thrombotically occluded catheters,
please visit www.cathflo.com or call Genentech Customer Service at 1-800-551-2231
to locate your local Genentech clinical specialist.
www.cathflo.com
© 2016 Genentech USA, Inc. All rights reserved. CAT/020215/0005(1) Printed in USA.
Keep central lines open