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Use of Convalescent Whole Blood or Plasma
Collected from Patients Recovered from Ebola Virus
Disease for Transfusion, as an Empirical Treatment
during Outbreaks




Interim Guidance for National Health Authorities and Blood
Transfusion Services

Version 1.0 September 2014



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© World Health Organization 2014
All rights reserved.
The designations employed and the presentation of the material in this publication do not imply the expression of any
opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city
or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps
represent approximate border lines for which there may not yet be full agreement.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this
publication. However, the published material is being distributed without warranty of any kind, either expressed or implied.
The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health
Organization be liable for damages arising from its use.
WHO/HIS/SDS/2014.8
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Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from
Ebola Virus Disease for Transfusion, as an Empirical Treatment during Outbreaks
Contents
1 Introduction
2 Guidance on donor selection, screening, donation and handling of blood
and plasma units
2.1 Identification of suitable blood or plasma donors among patients recovered from
Ebola viral disease (EVD)
2.2 Donor information, consent and selection
2.3 Donor’s blood grouping and TTI screening
2.4 Blood collection and donor care
2.5 Storage of whole blood and plasma units, inventory management and transportation
3 Guidance on transfusion of convalescent whole blood or plasma
3.1 Selection of EVD patients
3.2 Informed consent
3.3 Collection of patient’s blood samples for laboratory testing
3.4 Selection of convalescent whole blood or plasma unit for transfusion
3.5 Administration of convalescent whole blood or plasma
3.6 Patient monitoring
4 Other considerations
4.1 Human resource and supplies of critical materials
4.2 Infection control
4.3 Data collection, analysis and interpretation
Annexes
Annex 1: Example of a consent form for donation of convalescent whole blood or plasma
to treat Ebola virus disease

Annex 2: Example of a consent form for treatment with experimental convalescent whole
blood or plasma therapy
Annex 3: Example of a Data Collection Form: Treatment with convalescent whole blood
(CWB) or plasma transfusion (CP)






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1
Introduction
While there is no proven treatment available for Ebola virus disease (EVD), whole blood
collected from patients in the convalescent phase of infection has been used as an empirical
treatment with promising results in a small group of EVD cases.1 During the current ongoing
EVD outbreak, whole blood and plasma collected from EVD recovered patients has been
prioritized for investigation, as one of the treatment modalities. 2 The concept that this
treatment could be efficacious is biologically plausible, as convalescent plasma has been
used successfully for the treatment of a variety of infectious agents.3
This interim guidance to national health authorities and blood transfusion services outlines
the steps required to collect convalescent whole blood (CWB) or plasma (CP) from EVD
recovered patients for transfusion to patients with early EVD, as an empirical treatment
modality. It covers:
• The identification of patients recovered from EVD as potential blood donors;
•
informed consent and selection of donors;
• donor’s blood grouping and screening for transfusion transmissible infections (TTI);
• blood collection and donor care;
•
labelling, storage and data collection in blood transfusion services (BTS);
•
informed consent of EVD patients;
• patient’s blood grouping and compatibility testing;
•
storage and transportation of CWB/CP to the sites where transfusions is to be given;
•
selection of EVD patients for this intervention;
•
the clinical transfusion process;
• data collection at the transfusion site; and
• assessment of the effectiveness of this empirical treatment.
The convalescent WB or plasma should be collected, prepared, stored and transfused in
facilities capable of implementing the guidance provided in this document. If the transfusions
are planned to be given in a field situation, the WHO Checklist for essential items for blood
transfusion in emergency settings can provide a useful source of additional information.4
This interim guidance will be updated as further evidence and experience accumulates.
2
Guidance on donor selection, screening, donation and handling of
blood and plasma units
2.1
Identification of suitable blood or plasma donors among patients
recovered from EVD

1 Mupapa K, Massamba M, Kibadi K, Kuvula K, Bwaka A, Kipasa M, Colebunders R, Muyembe-Tamfum JJ.. Treatment of Ebola hemorrhagic
fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. J Infect Dis 179 Suppl 1:S18-23,
1999.
2 Statement on the WHO Consultation on potential Ebola therapies and vaccines
http://www.who.int/mediacentre/news/statements/2014/ebola-therapies-consultation/en/
3 Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: Passive immunotherapy for influenza and other
serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73.
4 WHO Checklist for essential items for blood transfusion in emergency settings
http://www.who.int/entity/bloodsafety/transfusion_services/essential-items_bts.pdf?ua=1
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Patients who have recovered from EVD and who have been discharged from Ebola
treatment centres or units could be potential donors for CWB/CP, from 28 days after their
day of discharge. Ebola neutralizing antibodies are expected to be most effective when
CWB/CP is sourced from the areas of on-going active Ebola virus (EBOV) transmission.
However, in circumstances where the demand is high and the system is challenged by an
overwhelming number of active EVD patients, CWB/CP could also be sourced from the
places linked to the current EVD outbreak in West Africa where the outbreak has come
under control.
A register or database of patients recovered from EVD as potential CWB/CP donors should
be created. Only those EVD patients who have been discharged according to the WHO
criteria as: 1) clinically asymptomatic and 2) twice tested negative for EBOV RNA by
molecular techniques, should be considered as potential donors. The two samples for EBOV
RNA testing should be taken at least 48 hours apart, and the test results should be negative
on each sample. Discharge records of EVD recovered patients should be reviewed before
considering them as potential CWB/CP donors.
The donor selection criteria used in the country should be reviewed in light of the potentially
life-saving impact of these specific donations. An appropriate risk assessment should be
done to assess the risk reduction value of each selection criteria against the risk impact of
exclusion of the donor. Where the risk to the donor or the patient is seen to be significantly
lower than the risk of non-treatment, consideration should be given to relaxing the donor
selection criteria for these specific types of donation. For example, if the current age for
blood donation in the country is 18-60 years, and there are significant numbers of EVD
recovered patients outside this age range, the national health authorities and BTS may
consider relaxing the donor selection criteria to widen the potential donor pool.
Given relaxed criteria, recovered patients who are less than the recommended lower age
limit for blood donation may donate blood with parental consent following a thorough medical
assessment, including an assessment of total blood volume to determine the acceptable
volume to be collected (≤15% of total blood volume for whole blood). Depending on the
weight or total blood volume of the potential donor, blood may be collected in small volume
(200 mL) blood collection bags. Those above the upper age limit for blood donation should
also be assessed by a physician for their suitability to donate. While certain donor selection
criteria could be relaxed, the donors selected for donation should be RNA negative for
EBOLA and for the transfusion transmissible infections listed in Section 2.3.
2.2
Donor information, consent and selection
When an EVD recovered patient has been identified as a potential donor, the need for
collecting his/her whole blood or plasma donation should be explained, emphasizing that this
could be useful as an empirical treatment for the EVD patients. Potential donors should be
informed that there will be no payment to them for their blood or plasma donation.
In the event that the potential donor agrees to be considered for CWB/CP donation, he/she
should be assessed for suitability to donate blood or plasma through a donor selection
process, including general health criteria such as weight, medical and social (i.e. behavioural
risk factors) history, basic physical examination and haemoglobin estimation.5

5 WHO Guidelines on blood donor selection http://www.who.int/bloodsafety/publications/guide_selection_assessing_suitability.pdf
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BTS staff should then obtain written informed consent (Annex 1) from the potential donor for
donation of a unit of whole blood or plasma for transfusion. Donor confidentiality should be
maintained to avoid any coercion to donate from the community.
2.3
Donor’s blood grouping and TTI screening
Potential donors who meet the WHO criteria of recovery from EVD (see section 1) and who
also meet the donor selection criteria identified above and have given informed consent
should then be subjected to pre-donation testing to assess final suitability for donation,
according to the national policy and routine procedures.
Pre-donation testing should include:
• ABO and RhD grouping
• Blood screening tests for HIV, HBV, HCV, syphilis and other locally transmitted
infections, as applicable
• Haemoglobin estimation (unless performed as part of the initial donor selection
process
• Where possible, titration of total Ebola antibodies and Ebola neutralizing antibodies
could also help in the qualification of the donor, particularly if the donor is willing to
continue serving as CWB/CP source.
Depending on the test to be performed and the assay system used, either serum or plasma
could be used for these tests. Two blood samples of five mL each should be collected for
these tests, one in EDTA for a plasma sample and the other one in a plain tube (without
anticoagulant) for a serum sample. Residual serum from these blood samples should be
stored in aliquots for retrospective antibody testing or any other tests, as required.
2.4
Blood collection and donor care
The results of the pre-donation testing should be reviewed. Potential donors who test
negative for all TTI tests and meet all other criteria of donor suitability should be selected for
CWD/CP donations. In the event that the time between the pre-donation testing and the
donation exceeds 48 hours then the routine TTI testing should be repeated at the time of
donation.
Whole blood donation should be collected in a single blood collection bag or if feasible, in a
double blood collection bag for the separation of plasma from the red cells by sedimentation
or centrifugation. Where possible CP could also be collected by apheresis procedure from
suitable donors. Plasmapheresis will enable collection and storage of large volumes of CP
that may be used for more than one patient.
The donor should be provided with good care before, during and after the whole blood or
plasma donation procedure. Any adverse donor reactions should be adequately and
promptly managed and recorded. The WHO Guidelines on drawing blood: Best practices in
phlebotomy may provide a useful source of information.6

6 WHO Guidelines on drawing blood: Best practices in phlebotomy
http://whqlibdoc.who.int/publications/2010/9789241599221_eng.pdf?ua=1
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A minimum period of 12 weeks for males and 16 weeks for females should occur before a
further whole blood donation is collected. The inter-donation interval for collection of plasma
by apheresis should be two weeks. The minimum interval before a plasmapheresis donation
should be four weeks following a whole blood donation or a failed return of red cells during
apheresis.
Potential donors with abnormal TTI test results should be referred to appropriate health-care
institutions for further investigation, confirmation, counselling, treatment and care.7
2.5
Storage of whole blood and plasma units, inventory management and
transportation
Donated CWB should be stored between +20C and +60C (never frozen) preferably in a
separate blood bank refrigerator dedicated to CWB/CP units, fitted with a temperature
monitoring system and alarm. In case a separate refrigerator is not available, consideration
should be given to storing these units on a separate, labelled shelf within the refrigerator.
The storage duration will depend on the anticoagulant and preservative solution in the blood
collection bag and must strictly follow manufacturer’s instructions. It may be stored up to 35
days if collected in citrate phosphate dextrose with added adenine (CPDA-1). Appropriate
labelling should be done to clearly identify CWB/CP units.
CP separated from whole blood donations or collected by apheresis may be stored as
‘Liquid Plasma’ between +20C and +60C in blood bank refrigerators for up to 40 days.
Alternatively, it may be frozen either within 8 hours of collection as ‘Fresh Frozen Plasma’ or
within 18-24 hours of collection as ‘Plasma Frozen Within 24 hours’ and stored for up to 12
months at or below -180C in a controlled plasma freezer.8
Where there are no facilities to prepare CP by centrifugation, it could be separated from
CWB collected in double bags. A CWB unit can be stored vertically for 24 hours between
+20C and +60C, the supernatant plasma can then be transferred into the secondary bag, and
stored as liquid plasma.
Careful inventory management procedures should be in place for these CWB/CP donations
collected, with full consideration of ABO and RhD blood groups and age of the CWB/CP
units, to minimize loss due to expiry. The CWB/CP units should be transported in
temperature controlled conditions.
Considerations shall be given to the need for extended storage of unused expired CWB/CP,
to make them available for research purposes.
3
Guidance on transfusion of convalescent whole blood or plasma
3.1
Selection of EVD patients
Only patients with confirmed EVD9, preferably in its early stages, should be considered for
CWB/CP transfusion, as an empirical treatment for EVD.


7 WHO/CDC/IFRC implementation guidelines: Blood donor counselling
http://www.who.int/bloodsafety/voluntary_donation/Blooddonorcounselling.pdf?ua=1
8 WHO Manual on the management, maintenance and use of blood cold chain equipment
http://www.who.int/entity/bloodsafety/Manual_on_Management,Maintenance_and_Use_of_Blood_Cold_Chain_Equipment.pdf?ua=1
9 Case definition recommendations for Ebola or Marburg Virus Diseases http://www.who.int/csr/resources/publications/ebola/ebola-
case-definition-contact-en.pdf?ua=1
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3.2
Informed consent
If feasible, informed consent for transfusion of CWB/CP should be obtained from the EVD
patient or the family members (Annex 2).
3.3
Collection of patient’s blood samples for laboratory testing
The patient should be correctly identified. Two venous blood samples of 5 mL each should
be collected from the patient prior to transfusion; one in EDTA for a plasma sample and the
other one in a plain tube (without anticoagulant) for a serum sample. These samples are for
(a) ABO and RhD blood grouping and cross-matching and (b) for baseline viral load assay.
One 5mL sample should be taken in a plain tube (without anticoagulant) for a serum sample
on the day after transfusion to measure viral load and for any other tests, as required.
Prior to discharge of patients that recover, two additional 5 mL samples (each in a plain tube
without anticoagulant) are required on consecutive days for viral load measurements.
Residual serum from these blood samples should be stored in aliquots for retrospective
antibody testing or any other tests, as required.
3.4
Selection of convalescent whole blood or plasma units for transfusion
ABO and RhD matched blood or plasma units should be selected for transfusion. RhD
negative units should be used for transfusion to RhD negative women of child-bearing age, if
feasible. If the RhD group of the patient is not known or in case of non-availability of RhD
specific group, blood matched only for ABO group may be used.
To reduce the risk associated with handling infectious blood samples, cross matching of
patients’ serum and donors’ red cells, may be omitted if ABO group compatible CWB/CP is
selected.
When it is not possible to test the patient’s ABO group or if ABO matched CWB/CP is not
available then:
• For whole blood transfusion: Group O convalescent whole blood, ideally from donors
with low titre anti-A and anti-B, should be used;
• For plasma transfusion: Group AB convalescent plasma separated by centrifugation
should be used.
o Non ABO-matched CP separated by centrifugation could also be considered
if group AB plasma is not available, but should preferably be group A or group
B.
CP prepared by 24-hour sedimentation should only be used for ABO group compatible
recipients due to the higher red cell concentration.
3.5
Administration of convalescent whole blood or plasma
CWB/CP units should be transfused to the EVD patients using standard clinical transfusion
procedures. One unit of CWB (collected in a 350/450 mL blood collection bag) should be
transfused for adult patients. In the absence of evidence, 400-500 mL of CP in two doses of
200-250 mL each, separated from two different WB donations, should be considered for
adult patients. For paediatric CWB/CP transfusion, a dose of 10 mL/kg could be used based
on the considerations of blood volume.
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Slow intravenous transfusion should be given with careful monitoring of the patient for any
acute transfusion reactions, particularly during the first 15-20 minutes. Transfusion should be
completed within 1-4 hours of commencement with monitoring and recording of the patient's
vital signs.
If frozen plasma is being used for transfusion, it should be thawed in a water bath between
+300C and +370C or other suitable thawing device before use and infused using a blood
administration set as soon as possible after thawing. The WHO Clinical Use of Blood
Handbook may provide a useful source of information.10
In areas with high malaria transmission, the recipient of the convalescent WB/CP transfusion
should be given a full treatment course with an effective antimalarial medicine, immediately
following the
transfusion. The first-line antimalarial
treatment
recommended for
uncomplicated malaria should be used for this purpose.11
The need for repeat transfusion of CWB/CP should be determined based on the clinical
response and if feasible, on the level of neutralizing Ebola antibodies in the donor and the
patient.
Records shall be kept to assure traceability between donors and recipients.
3.6
Patient monitoring
EVD patients receiving convalescent whole blood or plasma transfusion should be closely
monitored to assess the effectiveness of this intervention. In additional to clinical monitoring,
this would also include measurement of viral load, Ebola antibody levels and other tests,
according to the sampling scheme in section 3.3. Standard case reporting forms are being
developed to monitor all potential interventions for EVD, and the WHO website
(www.who.int/csr/disease/ebola/en/) should be consulted for the current version.
4
Other considerations
Countries should ensure that they have the capacity to support these interventions. This
includes adequate human resources and critical supplies, infection control procedures in
place, as well as the ability to collect, analyse and interpret data.
4.1
Human resource and supplies of critical materials
BTS should work with national health authorities to ensure that appropriate levels of
equipment, consumables and trained staff are available in the relevant regions for safe
blood collection from patients recovered from EVD, and for testing and adequate storage
and transportation of CWB/CP.
4.2
Infection control

10 WHO Clinical Use of Blood Handbook http://www.who.int/bloodsafety/clinical_use/en/Handbook_EN.pdf?ua=1
11 WHO Global Malaria Programme: Country antimalarial drug policies by regions
http://www.who.int/malaria/am_drug_policies_by_region_afro/en/
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The handling of blood samples from patients with EVD for blood grouping and cross-
matching by the hospital blood bank or laboratory personnel, should be done in accordance
with specific infection prevention and control guidelines for the handling and disposal of
highly infectious materials.12,13 Any serum/plasma samples being archived for future testing
should also be handled and stored in a similar manner. Standard safety precautions should
be followed for the handling of blood and plasma donations and samples from CWB/CP
donors.
4.3
Data collection, analysis and interpretation
Information on a minimum number of data elements for donors and patients should be
collected using a data collection form (Annex 3) primarily for health statistics purposes and
also for the assessment of patients’ response, without compromising the urgency of the
treatment. In order to assess the value of this treatment intervention, it is important to gather
data on patient outcome with respect to their EVD infection.
Data on any adverse reactions in donors or transfusion recipients should be documented as
part of the hospital or national haemovigilance system.

















12 WHO Interim infection prevention and control guidance for care of patients with suspected or confirmed filovirus haemorrhagic fever in
health-care settings, with focus on Ebola, WHO, Geneva, 2014.
http://apps.who.int/iris/bitstream/10665/130596/1/WHO_HIS_SDS_2014.4_eng.pdf?ua=1&ua=1
13 WHO Guidance: How to safely collect blood samples from persons suspected to be infected with highly infectious blood-borne
pathogens http://www.who.int/csr/resources/publications/ebola/blood-collect-en.pdf?ua=1

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Acknowledgements:
This interim guidance has been developed by the WHO-HQ Department of Service Delivery and Safety in collaboration with the
Departments of Pandemic and Epidemic Diseases, Knowledge, Ethics and Research & Essential Medicines and Health
Products; and WHO-AFRO Divisions of Health Systems and Services & Immunization, Vaccines and Emergencies and
includes comments from WHO Global Blood Safety Network; WHO Experts on Blood Transfusion Medicine and Biological
Standardization from Bhutan, Cameroun, Hong Kong SAR, China, Ghana, Honduras, Italy, Malaysia, New Zealand, Singapore,
South Africa, UK and USA; WHO Blood Regulatory Network; WHO-AMRO/PAHO Division of Health Systems and Services;
Centers for Disease Control and Prevention, Atlanta; International Severe Acute Respiratory and Emerging Infection
Consortium; African Society for Blood Transfusion; ICCBBA; European Blood Alliance; International Society of Blood
Transfusion; and AABB.



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Annex 1
Example of a consent form for the donation of convalescent whole
blood or plasma to treat Ebola virus disease


1.
General information about Ebola virus disease (EVD) and convalescent whole
blood or plasma for EVD treatment
Ebola virus disease (EVD), also called simply Ebola, is a disease transmitted through close
contact with the blood, secretions, other bodily fluids, or organs of infected animals and
people. Some of the symptoms of the disease include fever, nausea, vomiting, headache,
diarrhoea and bleeding. The disease is often severe and in the best health facilities only 3-5
out of 10 patients recover.

Except for some experimental treatments, no treatment or vaccine is currently available to
treat or prevent EVD. Only a few primary prevention measures have been established
focusing on avoiding direct contact with the body fluids of animals and people infected with
the virus. If a treatment for EVD could be found, it would save many lives.
People like you, who have recovered from EVD, did so, because your body was able to fight
the disease and now your blood contains substances which are capable of fighting EVD.
This ability remains for life – that is you will never have EVD again, even if the Ebola virus
enters your body again. We think that patients who currently have the disease, could
improve faster if they received some of your blood or plasma (the liquid part of your blood)
that has the ability to fight EVD. But we don't know this for sure. It is possible that a patient
with EVD may not recover, even after receiving blood from a person who has recovered from
EVD. Because we don't have any other treatment option at present, we would like to try it in
case it is successful, as it has been for certain other viruses. You could think of this as a gift
to another person.
To try out this treatment, we will first ask you to allow us to review your medical records from
the health facility which treated you for Ebola, to assess if you can safety donate blood or
plasma.
2.
What will happen if you agree to donate blood?
a) Testing your blood
If you agree to donate some blood or plasma for the treatment of EVD, we will ask you to
come to the blood donation centre and we will first take a small amount of your blood
(about 10 mL), about a tablespoonful, from a vein in your arm using a single use sterile
syringe and needle and do some tests that will tell us the type of blood that you have and
also whether your blood can be used for treatment of EVD. If the amount of haemoglobin
is too low or if your blood has the possibility of causing disease in another person, or you
are not able to donate due to some other reason, we will not be able to accept your
blood donation. If that happens, we will explain to you in detail the reasons why your
blood cannot be taken, and if you need to have any medical treatment. If, however, you
are suitable to donate, we will arrange a suitable time for the donation.




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b) Collection and storage of blood or plasma units
For the donation, we will ask you to come to the blood donation facility, where you will be
given something to drink (water or juice) before the donation of blood or the liquid part of
your blood (plasma). Donating blood is very simple. The nurse/doctor will then ask you to
lie on a couch or clinic bed. The inner area of one of your elbows will be cleaned with an
antiseptic solution before a trained health worker inserts a sterile needle, connected to a
blood bag, into your vein. The volume of blood taken will be about 350-450 mL. It usually
takes only about 10 minutes to donate a unit of blood.
If you are donating the plasma on a special machine, a trained health worker will put a
small needle into a vein in your arm, through a sterile single use needle, after making
that part of the arm numb. A small tube will be connected to a machine that will collect
the liquid part of the blood into a separate bag, and return the red part of your blood back
to your body. To stop the blood from clotting, a liquid, known as an anticoagulant, will be
automatically mixed with the blood as it is pumped from the body into the machine. The
trained health worker will collect about half a litre (e.g. small mineral water bottle) of
plasma. This procedure will take about 45-60 minutes.
You will be given light refreshments after the procedure. After resting for about 15-30
minutes, you will be able to return to your normal activities, although you should avoid
strenuous activities for the rest of the day. You should drink plenty of fluids over the next
24 hours. Your body will replace the lost fluid within about 36 hours.
c) What happens next?
The blood that has been collected will be stored in a refrigerator with an identification
number. If plasma has been collected or separated from your whole blood donation, it
will also be stored in a refrigerator or freezer. It will not have your name on it. The
remaining red cells may or may not be used. When there is a patient who is likely to
benefit from the use of blood or plasma donated by you, it will be taken out from the
stock, and brought to room temperature, and then given to the patient through a vein.
We will keep a close watch on the patient and record everything, so that we learn from
the experience and know more about its use in the treatment of EVD.
3.
Possible risks and discomforts
Taking blood from your arm may sometimes cause bruising, mild pain or discomfort and in
very rare circumstances, infection. We will take all preventive measures to minimize these
risks. Some people may feel light-headed or little giddy, especially while donating plasma.
This lasts for only a few minutes and quickly subsides.
4.
Confidentiality
Any information that you provide and all test results will be treated confidentially. The
medical staff who test your blood have the responsibility to inform you of all the blood test
results, and to advise you on any treatment they think you will require.
5.
Will I know who receives my blood?
A patient with early EVD would receive your blood. It is difficult to predict who exactly will
receive the blood that you donate. The person must have a compatible blood type to yours.
Your name will not be on the blood or plasma you have donated, it will just be identified with
a unique donation number. So no one will know whose blood is being given to the patient.
And you will not know who receives it either. But be assured that it will be used for a patient
who requires it and all information about you and your donation will remain confidential.
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6.
Will the person who receives the blood know who has provided it?
No. no-one, including the person who receives your blood, will know who has provided the
blood. This is so that your privacy can be protected.
Be assured that the blood or plasma that we collect will be treated with respect.
7.
Expenses and payments
There will be no charges to you for any cost related to this donation. There will be no
payment for you to participate in this donation either.
8.
Participation and withdrawal from donation
You are free to decide whether or not to donate blood or plasma. If you do not meet the
donor suitability criteria, you will be immediately informed by the doctor in charge …………...
Once your blood and/or plasma has been collected, you can request that it is withdrawn at
any time prior to it being transfused to a patient by informing the attending doctor.
You cannot request that your blood or plasma donation should not be used for transfusion,
once it has been given to a patient. Your decision to request the discard of your blood or
plasma, if it has not been transfused, will not affect your future care.
9.
Who to contact if you have any questions
If you have any questions, feel free to contact us at the blood centre ……………..

Your signature documents your permission for the donation.

Signature of Donor:


x________________________
Full Name:


x_______________________________
Date of Signature:


____/____/_____









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Annex 2
Example of a consent form for treatment with experimental
convalescent whole blood or plasma therapy
1. Information about the disease
You/your child/family member has been diagnosed with Ebola virus disease (EVD). The
disease is transmitted through close contact with the blood, secretions, other bodily fluids or
organs of infected animals and people. Some of the symptoms of the disease include fever,
nausea, vomiting, headache, diarrhoea and bleeding. The disease can be quite severe and
in the best centres only 3-5 out of 10 patients recover.

Currently, no medicine exists that has been tested in human beings so we don't have any
medicines or vaccines to treat or prevent EVD. Only a few primary prevention measures
have been established focusing on avoiding direct contact with the body fluids of animals
and people infected with the virus. If a treatment for EVD could be found, it would save many
lives.

People who recover from EVD do so because their blood contains substances which are
capable of fighting EVD. This ability remains for life, meaning that they will never have EVD
again, even if the germ enters their body again. We think that patients with EVD might
improve faster if they received the blood or plasma (the liquid part of blood) from those who
have recovered from EVD, because it may have the ability to fight EVD.

2. What are we asking you?
We are asking you if you/your child/family member would consider receiving blood or plasma
from someone who has recovered from EVD. Their blood and plasma will have substances
that could improve your/your child’s/family member’s chances of recovery.

We don't know if this treatment will help you/them or not, and we don't know if it will have
any harmful effects either, but this is the only treatment that we have at present, but you
need to know that it has not yet been tested in humans. Because we don't have any other
treatment option at present, we would like to try it out, and learn from the testing.

3. What will you be asked to do if you ask to receive this treatment?
You/your child/family member will be given the blood or the liquid portion collected from the
blood of a person who has recovered from EVD. It will be given into one of your/their veins,
using a sterile single use needle, and will be given over the course of about one hour. About
350-450 mL of blood or 200-500 mL of plasma separated from the blood will be given at
each treatment. Depending on tests that will be carried out on your blood/the blood of your
child/family member after this treatment, it could be repeated in the following days with blood
or plasma from different donors.

Because this therapy has not yet been tested in humans, and you want to try this new
therapy, we would like to learn as much as possible about its effects on human beings. We
will therefore record as much information about you and your response to the treatment as
possible.




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4. Can I change my mind after I say ‘Yes’:
Yes, you can change your mind at any time. If you wish to stop the treatment, just tell your
doctor. Your decision will not stop you from getting the usual care that all patients receive at
this centre.

5. What is the benefit from receiving this treatment?
We cannot promise that this treatment will help you because we are not certain how good
convalescent blood or plasma is for treating Ebola. However we believe that this treatment
might be effective in improving the likelihood of you/your family member recovering from the
disease.
6. What are the risks from receiving this treatment?
Blood and plasma have been used for many other conditions, and in general are very safe.
Although the risk of contracting Ebola infection from receiving the treatment has not been
tested yet, we believe that it would be low as the blood has been tested negative for the EVD
virus and because the donor has fully recovered from the infection. Transfusion also carries
the risk of adverse reactions and transmission of infections including HIV and Hepatitis B
and C, though these risks are low as only screened and compatible blood is used for
transfusion.

7. Do you have other choices?
You can choose to get this treatment or not. Your choice will not affect the care that you are
receiving at this centre. We will always do our best to take care of you. If you agree to this
treatment, you will also be helping us learn whether the treatment works and how it works to
help other patients, though you can withdraw at any time.

8. What treatment costs will be paid?
You will not have to pay anything to receive this treatment.

9. How will your privacy be protected?
Your medical records will only be reviewed by the doctor and nurses who are treating you
and other appropriate regulatory authorities. Additionally, all the information or data collected
on you to help understand if the therapy is effective will be kept confidential and only be
used by specialists to better understand EVD and its potential treatment(s).

10. Who can I talk to?
If you have questions, concerns about the treatment or medical problems, you can talk to
your doctor.

Your signature documents your permission to use this experimental treatment.

Signature/thumbprint of Patient:


x________________________
Full Name:


x_______________________________
Date of Signature:


____/____/_____

If the patient is unable to give consent (i.e. incapacitated), consent from the next of kin can
be obtained:
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Signature/thumbprint of
Next of Kin:


x______________
Full Name:



x______________________
Relationship to Patient

x



Date
of
Signature:


____/____/____
_

If the patient is a minor, consent from the parent or next of kin, and if possible, assent of the
child to be obtained:
Signature/thumbprint of
parent/next of kin


x______________
Full Name:



x______________________
Relationship to Patient

x



Date
of
Signature:


____/____/____
Signature/thumbprint of
child
Full name

Date
of
Signature


I, the undersigned, have fully explained the relevant information of this treatment to the
person named above and will provide her/him with a copy of this signed and dated informed
consent form.



x___________________


x___________________________________


___/____/_____
Physician Signature
Full Name
Date of Signature

If the person giving consent cannot read the form themselves, a witness must be present
and sign here:
I was present with the patient throughout the entire informed consent process. This form was
read accurately to the patient, all questions from the patient were answered and the patient
has agreed to the treatment.


x_______________


x__________________________________


___/____/_____
Witness Signature/thumbprint
Full Name
Date of Signature











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Annex 3







Confidential
Example of a Data Collection Form
Treatment with convalescent whole blood (CWB) or plasma transfusion (CP)
Donor Records
Date of donation

Place of donation

Registration number

Blood or plasma unit
number

First name

Family Name

Age

Gender

Nationality

Date of discharge
from EVD treatment
centre

Weight

Temperature & Pulse

BP

Haemoglobin

ABO blood group

RhD blood group

EBOV RNA results #1
Tests done on

EBOV RNA results #2
Tests done on

HIV test result

Marker tested

HBV test result

Marker tested

HCV test result

Marker tested

Syphilis test result

Marker tested

Any other infection(s)

Marker(s) tested

Total antibody titre to
EBOV

Neutralizing antibody
titre

Volume of blood
collected
Date of donation

Type and volume of
anticoagulant



Donor reaction
yes/no
Type of reaction

CWB expiry date
CP expiry date

Donor serum sample
archived
yes/no
Name of staff
collecting blood


Patient Records
Date of transfusion

Place of transfusion

Registration number

Date of onset of EVD

First name

Family Name

Age

Gender

Patient’s ABO group

Patient’s RhD group

Nationality

Product transfused
CWB/CP
Convalescent plasma Liquid plasma by
sedimentation
Liquid plasma by
centrifugation
Thawed from Fresh
Frozen Plasma
Blood or plasma unit
number transfused

ABO and RhD group
of unit transfused

Time of starting
transfusion

Time of completing
transfusion

Patient vital signs



Transfusion reaction
yes/no
Type of reaction

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Volume transfused

Name of staff
performing clinical
transfusion

Patient serum sample
archived
yes/no


Patient monitoring after transfusion
Clinical follow up

Date

EBOV RNA

Date

Viral load

Date