Download Generic SOP - Ebola Clinical Trials

Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
SOP Ref No
BCV001_SOP04
SOP title
Anaphylaxis management
Version
1.1
Date issued
29th December 2014
Valid until
28th December 2016 (maximum of 2 years)
Author(s)
Name:
Jake Dunning
Signature:
Approved by
Date:
……………………
Name:
Peter Horby
Signature:
Date:
29th December 2014
Modification history
Version No
Date
Author(s)
1.1
29/12/2014
Jake Dunning
BCV001_SOP04 Anaphylaxis management V1.1 29th December 2014
Date reissued to
previous recipients
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
Standard Operating Procedure
1. Purpose
The purpose of this standard operating procedure (SOP) is to ensure rapid identification and
treatment of anaphylaxis in any patient following administration of the Investigational
Medicinal Product (IMP), brincidofovir (BCV).
2. Scope
This SOP details the definition of anaphylaxis and its treatment within the Ebola Treatment
Unit. It is only applicable to patients enrolled in the RAPIDE-BCV trial.
3. Responsibility
Trial staff will be responsible for observing patients at 30 minutes after administration of the
IMP; standard arrangements for supervision by site treating staff are applicable at all other
times. Either trial staff or treating staff may be responsible for treating anaphylaxis that may be
related to BCV administration. This anaphylaxis protocol will be shared with site staff involved
in patient care. Copies should be kept in high-risk and low-risk clinical areas, and in pharmacy,
and in the anaphylaxis packs. Anaphylaxis packs and all medications are to be kept in Pharmacy,
due to the requirement for temperature control; they must not be stored in the high-risk area.
4. Procedure
4.1. Definition of anaphylaxis for patients who have been enrolled into the RAPIDE-BCV
trial:
1. Acute-onset, life-threatening illness of rapid onset and evolution
2. Occurring within 1 to 120 minutes of BCV administration
3. With the following signs and symptoms:*
 AIRWAY: swelling of oropharyngeal tissues; hoarseness; stridor; and/or
 BREATHING: rapid breathing; wheeze; fatigue; cyanosis; confusion; and/or
 CIRCULATION: pale; clammy; faintness; drowsy/coma;
plus
 SKIN: hyperaemia; severe itching; flushing; swelling; rash (especially
urticaria).
*Each sign may be completely new, or may represent acute worsening of a pre-existing
sign/symptom e.g. worsening of rapid breathing. Note that all signs/symptoms may not
be present.
4.2. If an ETU patient has a suspected anaphylactic reaction following administration of
BCV:
4.2.1. Ensure your own safety first; follow PPE and site safety rules at all times and
work with your buddy.
4.2.2. Ask for help from other medical staff in the high-risk area if needed.
BCV001_SOP04 Anaphylaxis management V1.1 29th December 2014
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
4.2.3. If the patient is already in bed, lie them flat.
4.2.4. If the patient is not in bed, lie them flat in the area in which they are found, as
long as it does not compromise the safety of staff or other patients. Call for a
stretcher if the patient needs to be moved.
4.2.5. Reassure the patient if they are conscious
4.2.6. Ensure that the medical staff in low-risk area are informed that a patient is
having an anaphylactic reaction; ask staff to send more medical help, if needed.
4.2.7. Ask a member of staff from low-risk to go to pharmacy to obtain either an adult
anaphylaxis pack or a child anaphylaxis pack, as appropriate for the age of the
patient. The same member of staff should then pass the anaphylaxis pack to the
high-risk area using the chute.
4.2.8. Wash your gloved hands with 0.5% chlorine.
4.2.9. Obtain a sharps bin, which can be found in the medical cupboard in each
confirmed tent, and place it at the bedside.
4.2.10. Wash your gloved hands with 0.5% chlorine.
4.2.11. The buddy, or another member of staff, should obtain a 0.5% chlorine spray unit,
to be placed at the bedside.
4.2.12. Remove the adrenaline (epinephrine) Auto-Injector carrier tube from the
anaphylaxis kit.
4.2.13. Ensure you have selected the correct adrenaline Auto-Injector before
administering the dose:
 Yellow EpiPen is for individuals weighing 30 kg or more
 Green EpiPen Junior is for individuals weighing less than 30 kg
BCV001_SOP04 Anaphylaxis management V1.1 29th December 2014
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
4.2.14. Flip open the cap of the carrier tube (yellow cap for EpiPen; green cap for EpiPen
Jr) and carefully tip the carrier tube and slide out the Auto-Injector.
4.2.15. Expose the patient’s thigh. If the patient’s clothes cannot be removed to expose
the thigh, then the device can be administered through clothing.
4.2.16. Spray your gloved hands with 0.5% chlorine.
4.2.17. Prime the Auto-Injector by removing the blue safety release, pulling it straight
upwards without bending or twisting it (see figure 1, below).
4.2.18. Do not put your fingers over the orange tip (where the needle will come out).
4.2.19. Holding the Auto-Injector perpendicular (90°) to the patient’s outer thigh, push
the orange tip firmly into the patient’s thigh until a click is heard (needle
automatically inserted) and maintain contact for 10 seconds (see figure 2, below).
BCV001_SOP04 Anaphylaxis management V1.1 29th December 2014
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
4.2.20. Remove the device from the patient’s thigh. The needle will have automatically
retracted.
4.2.21. Dispose of the Auto-Injector in the sharps bin immediately.
4.2.22. Spray your gloved hands with 0.5% chlorine.
4.2.23. Obtain the blood pressure machine and measure the patient’s blood pressure.
4.2.24. If the systolic blood pressure is <90 mmHg, then give an intravenous fluid
challenge, if it safe to do so:
 Adult: 500 mL – 1000 mL Ringer’s Lactate
 Child: 20 mL/Kg Ringer’s Lactate
 If the patient does not have a peripheral venous cannula in situ, then insert a
cannula, but only if you have been trained and are authorised to cannulate. If
you cannot cannulate, then arrange for insertion of a cannula by an
appropriately trained member of staff. Follow the site safety policy for
cannulation at all times. Do not insert a cannula if it is considered unsafe to
do so.

Spray gloved hands with 0.5% chlorine after patient contact
4.2.25. Reassess the patient 5 minutes after the EpiPen (or EpiPen Jr) injection was
given. If the patient’s condition has not improved or has deteriorated, another
dose of IM adrenaline may be given using a new EpiPen (or EpiPen Jr, as
appropriate). Additional Auto-Injectors may be obtained from the Low Risk Area.
Follow points 4.2.9-18 above if a second dose needs to be given. Remember to
spray gloved hands with 0.5% chlorine before and after administering any further
doses of IM adrenaline using the Auto-Injector.
4.2.26. Ask the medical staff in the low risk zone to prepare a solution of
dexamethasone for intramuscular (IM) injection, according to the protocol that is
displayed in the low risk area. Instruct them which dose to prepare, according to
the following table:
Dexamethasone IM
Adult, or child over 12 years 8 mg
Child 6 to 12 years
4 mg
Child 6 months to 6 years
2 mg
Child less than 6 months
1 mg
4.2.27. Have the sharps bin at the bed side
4.2.28. Expose the opposite thigh to the one used for the EpiPen injection(s)
4.2.29. Spray gloved hands with 0.5% chlorine
4.2.30. Give the injections of dexamethasone by intramuscular injection into the
exposed thigh. Dispose of all sharps and syringes immediately in the sharps bin.
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
4.2.31. Spray gloved hands with 0.5% chlorine
4.2.32. If the patient has itching and/or urticaria, and the patient is conscious and able
to swallow tablets safely, or swallow syrup/suspension (if available), then oral
cetirizine should be given. Ask staff in low risk to obtain the correct dose of oral
cetirizine from Pharmacy. Administer the correct dose, according to the following
table:
Oral cetirizine
Adult, or child over 6 years 10 mg
Child 2 to 5 years
5 mg
Child 6 months to <2 years 2.5 mg
4.2.33. If the patient has itching or urticaria, and the patient is unconscious or has
reduced consciousness, or is not able to swallow oral cetirizine for any reason,
then an intramuscular chlorphenamine injection may be given, in place of oral
cetirizine.
4.2.34. If injectable chlorphenamine is available on site, then ask the medical staff in the
low risk zone to prepare a solution of chlorphenamine for intramuscular (IM)
injection, according to the protocol that is displayed in the low risk area. Instruct
them which dose to prepare, according to the following table:
Adult, or child over 12 years
Child 6 to 12 years
Child 6 months to 6 years
Child less than 6 months
Chlorphenamine IM
10 mg
5 mg
2.5 mg
250 micrograms per Kg
4.2.35. To give IM chlorphenamine, have a sharps bin available at the bedside
4.2.36. Expose the opposite thigh to that used for adrenaline (EpiPen) injections
4.2.37. Spray gloved hands with 0.5% chlorine
4.2.38. Carefully administer the chlorphenamine by intramuscular injection into the
exposed thigh
4.2.39. Immediately dispose of the syringe and vial in the sharps bin
4.2.40. Spray hands with 0.5% chlorine
4.2.41. Call for the Medical Team Leader and the Trial Clinical Lead, to provide further
assistance and advice.
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5. References
5.1. Resuscitation Council (UK) Anaphylaxis Algorithm.
http://www.resus.org.uk/pages/reaction.pdf
5.2. Anaphylaxis: rapid recognition and treatment. UpToDate. Topic 392 Version 20.0.
Updated 18 Dec 2014. http://www.uptodate.com/contents/anaphylaxis-rapidrecognition-and-treatment
5.3. MSF Clinical Guidelines – Diagnosis and Treatment Manual. 2013 Edition. Médecins
Sans Frontières.
5.4. MSF Essential Drugs – Practical Guidelines. 2013 Edition. Médecins Sans Frontières.
BCV001_SOP04 Anaphylaxis management V1.1 29th December 2014
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