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Whole Blood Project ( different clinical needs – different strategies ) Dr Soraya AMAR EL DUSOUQUI Dr Emmanuel RIGAL. Agenda. Brief description of the project and WB indications Definition „s“ of whole blood - PowerPoint PPT Presentation
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Whole Blood Project
( different clinical needs – different strategies )
Dr Soraya AMAR EL DUSOUQUI Dr Emmanuel RIGAL
Regional blood transfusion centre Geneva – Haematology departement HUG 1
Agenda
① Brief description of the project and WB indications
② Definition „s“ of whole blood
③ Distribution of WB and components in 10 BTS in SSA and 10 European countries
④ Plasma production in countries with limited resources
⑤ 2 major aspects of transfusion in Sub Saharan Africa
⑥ Epidemiological facts concerning HIV in Sub Saharan Africa
⑦ Different situation - different needs - different strategies
⑧ Is there an interest in FWB transfusion?
⑨ Conclusions
Regional blood transfusion centre Geneva – Haematology departement HUG 2
Regional blood transfusion centre Geneva – Haematology departement HUG
Brief description
collection pathogen inactivation transfusion
research on PI in whole blood bags using Intercept RBC PI technology S-303 combined with glutathione on whole blood
3
WB transfusion indications
Indications for whole blood transfusions:
• Where WB cannot be separated into components (75 % of transfusions in low resource countries )
• In the military battlefield where WB can be an alternative to treat acute massive trauma. The US Military has transfused >8000 units of FWB over the last 8 years
• As an alternative in case of acute massive need ? Terrorist attack / epidemic outbreak ?
Regional blood transfusion centre Geneva – Haematology departement HUG 4
Description of project phases
Regional blood transfusion centre Geneva – Haematology departement HUG
•Project plan •resources•Secure budget
•Establish treatment process•product requirements
Phase 1
• Obtain ethic review• in vitro studies to
support clinical trials • Identify potential
sites in Africa• Training of
collaborators in conduction of clinical trials
Phase 2
• ethics and regulatory review approval for the conduct of clinical trials
• Obtain Swiss and African country health authority and haemovigilance board acceptance
• Conducting clinical trials in Africa
• Plan implementation of product
• Creation of a bi-national data and safety management board
Phase 3
5
Regional blood transfusion centre Geneva – Haematology departement HUG
USA WB Definition for military service :
warm Fresh WB used before 8 hours
Fresh WB stored at 1-6 °C cooled within 8 hours for max. 24h
USA WB Definition in civilian context :
fresh WB that is stored at 2°C to 6°C for max. 48 hours
Definition in African transfusion manuals :
warm Fresh WB used before 8 hours or
WB stored at 4°C for 28-35 days
6
Definition „s“ of whole blood
Regional blood transfusion centre Geneva – Haematology departement HUG
Austria Belgium Denmark France Hungary Ireland Holand Slovenia Switzerland Sweden0
10
20
30
40
50
60
70
80
90
100
Whole blood RCCFFPPC
10 European countries
7
Distribution of blood products in 10 European countries
The Collection, Testing and Use of Blood and Blood Components in Europe EDQM 2008
Regional blood transfusion centre Geneva – Haematology departement HUG 8
Distribution of WB and components in 10 BTS in SSA
Tayou-Tangy et al Trans Clininque et Biologique 2009
Regional blood transfusion centre Geneva – Haematology departement HUG 9
Plasma production in countries with limited resources
WHO suggests to low countries to assess the clinical demand and feasibility of component processing
Low income countries are hardly capable of investing their resources in
- Processing whole blood into components - Buying and maintaining material to process plasma in 8-24h and keep at < - 25°C- Monitoring and managing quarantine and stock
- Use surplus for producing medicinal products send to fractionation- Perform up to 5 – NAT testing- Abide to GMP standards
- Buy from pharmaceutical firms drugs derived from plasma
Regional blood transfusion centre Geneva – Haematology departement HUG 10
Plasma production in countries with limited resources
Regional blood transfusion centre Geneva – Haematology departement HUG 11
2 major aspects of transfusion in Sub Saharan Africa
Regional blood transfusion centre Geneva – Haematology departement HUG
42%
20%
26%
12%
Transfusion indications in Uganda
PediatricObstetrical and gynecolog-icalMedical surgical
2%2%
55%
41%
Transfusion RBC indications in USA
PediatricObstetrical and gynecolog-icalMedical surgical
The 2011 National Blood
Collection and Utilization Survey
Report
Natukunda et al, Transf Med 2010;20:134
12
2 major aspects of transfusion in Sub Saharan Africa
Regional blood transfusion centre Geneva – Haematology departement HUG
39%
27%
16%
7%
5%6%
Clinical transfusion indications in Uganda
Malaria
bleeding
Infection
cancer
Trauma/ surg
other
5.70%
1.60%
1.80%
2.10%
15.10%
0.80%
Bleeding causesGI
Epistaxis
Soft tissue
Perinatal
Obstetric
Other
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2 major aspects of transfusion in Sub Saharan Africa
Natukunda et al, Transf Med 2010;20:134
Regional blood transfusion centre Geneva – Haematology departement HUG 14
HIV epidemiological facts on HIV in Sub Saharan Africa
Regional blood transfusion centre Geneva – Haematology departement HUG 15
HIV epidemiological facts on HIV in Sub Saharan Africa
Regional blood transfusion centre Geneva – Haematology departement HUG 16
HIV epidemiological facts on HIV in Sub Saharan Africa
Regional blood transfusion centre Geneva – Haematology departement HUG 17
Different situation - different needs - different strategies
WHO Guidelines for the treatment of Malaria 2010
Assessing clinical demand in SSA countries :
BB have to respond very frequently to bleeding indications ( ex. U 27%) Adapt transfusion in hemorrhagic shock and coagulopathy situations :
- Use warm whole blood or components 1:1:1 RBC: FFP: PC or RBC: liquid plasma: PC ( no RCT to compare )
- need for fresh products (PLT functions and CF decrease with storage and cooling at 4°C° and they keep them stored up to 35d)
- Recent studies suggest that storage lesions affects outcome especially in critically ill patients
Regional blood transfusion centre Geneva – Haematology departement HUG
18
Different situation - different needs - different strategies
BB have to respond even more frequently to paediatric needs - children under 5 y (ex.U 42 %)
Adapt transfusion : - division into smaller bags - Fresh products ( K+) - Malaria : Indicated when Hb < 4 g/dl or <5g/dl if hyperventilation and anaemia- irradiation if family donor or HIV (argument for PI)- CMV neg for HIV patients ( argument for PI)
Adapt treatment strategies - Avoid malnutrition anaemia – food fortification- avoid iatrogenic anaemia- Malaria and parasite prevention- Iron / folate medication - rEPO ( optimal dose and timing ? Retinopathy age < 4 m )
Regional blood transfusion centre Geneva – Haematology departement HUG
19
Different situation - different needs - different strategies
Regional blood transfusion centre Geneva – Haematology departement HUG 20
Different situation - different needs - different strategies
Vox sanguinis 2010Uganda
biological rational for FWB with life threatening haemorrhagic shock and coagulopathy
Pros
increased concentration of cellular components
less volume transfused
fresh RBC cells - less storage lesions
fresh PLT
Temperature of wFWBhypothermia related dysfunction of coagulopathy
enzymes, platelets, Endothelial cells
lesser donor number exposure
contras
less time for viral screening tests ( need for PI)
transfusion of higher number of leucocytes risk T-GVH
lack of clear clinical evidence
- Irradiation - pre-storage leucoreduction
- PI
Regional blood transfusion centre Geneva – Haematology departement HUG 21
Is there an interest in FWB transfusion?
Service - Secteur - Département… Regional blood transfusion centre Geneva – Haematology departement HUG
Clinical data on use of whole blood
Setting References Study Method Patients product primary outcome/study results
combat J trauma 2009 -
Spinella et al.
retrospective US casualties
Iraq /Afghanistan
FWB+CT vs. CT
*24h survival *30d survival
WB vs. CT 96/100(96%)vs. 223/254(88%) - p value 0.01895/100 (95%) vs. 209/254(82%)-p value 0.002
inability to adjust for all confounders-survivorship bias
combat Transfusion
2011 Perkins JG
retrospective US and non US FWB+CT vs. CT
*24h survival *30d survival
WB vs. CT 69/85 [81%] vs. 239/284 [84%] p = 0.52)39/68 [57%] vs. 106/177 [60%] p = 0.72).
significant loss of follow up in CT at
30d (33%)
civilian Transfusion
2011 Ho and
Leonard retrospective
cardiac surgery, trauma,bleeding
FWB+CT vs. CT
coagulation profile30d and 8 year
survival
WB vs. CT fibrinogen 1.7 g/L vs.1.4 g/L, p = 0.006;
worst INR, 2.4 vs. 2.8, p = 0.05no significant increase in BP consumptionno significant long term survival p = 0.93
all used both WB and CT
Is there an interest in FWB transfusion?
22
Service - Secteur - Département… Regional blood transfusion centre Geneva – Haematology departement HUG
Clinical data on use of whole blood
Setting References Study Method Patients product primary outcome/study results
civilian Blood 1991manno et al
randomized controlled trial
(RCT)
children cardiac surgery n=161 n= 93 < 2y
3 groups
vfWB/48hWB/reconstituted WB
mean 24 h blood loss <2y
mean 24h blood loss > 2y
30 min /3h in vitro PLT aggregation
vfWB vs. two others in < 2y p:0.001
vfWB vs. two others in > 2y p:0.041
PLT aggregation lower in bothWB arms p:0.03
civilian NEMJ 2004MOU SS et al
single centre RCT
children cardiac surgery Reconstituted vs. FWB
composite score survival and length of
stay in ICU
no difference in outcome or survival
FWB longer length of stay RB
70.5 hours vs. 97.0 hours, P=0.04
length of stay was an
unadjusted outcome and FWB was only given intra-
operatively and not post
operatively
civilian paediatric
anaesthesia Friessen et al.
RCT n=32 Children non complex open heart
surgery autologus FWB vs. control
primary outcome was coagulation status
Secondary outcomes post op 24 h blood loss
increased platelet count, PT, and fibrinogen (P <
0.05)PO blood loss less (P = 0.036) in the treatment
group when measured as ml per 24 h, but not
significantly less (P = 0.16) when measured as
ml·kg per 24 h
Is there an interest in FWB transfusion?
23
Potential mechanisms of potential storage lesions of RBC
Service - Secteur - Département…
Vaso-regulatory systemCoagulations system
Immune system
(Spinella PC, Sparrow RL, Hess JR, Norris PJ. Transfusion 2011;51:894 –900)
Critically ill patients are most vulnerable
Regional blood transfusion centre Geneva – Haematology departement HUG 24
Is there an interest in FWB transfusion?
Conclusions:
• Most of the transfusions in SSA concern children and young females .
• Main medical indications in SSA are massive haemolysis due to malaria and obstetrical bleedings.
• The point of view of a large number of transfusion specialists in sub-Saharan Africa is that FWB is the product of choice for bleeding.
• Exploring whether FWB is an appropriate option in certain circumstances is warranted ( shock and coagulopathy , combat trauma when components unavailable, extreme disaster situations) .
• Blood banks will probably need to move toward more tailor made answers for patients and for clinical needs
• Warm FWB trials may be possible in the developing world and could help answer our questions.
Regional blood transfusion centre Geneva – Haematology departement HUG 25
Acknowledgements :
• Dr Schwabe • Dr Mansouri• Prof. Cazenave, Etablissement Français du Sang (EFS), Alsace, France• CERUS COOPERATION society• The directors of the Suisse Regional Transfusion Centres • Yvonne Fischer• Verena Flück• Daniella Lev
Regional blood transfusion centre Geneva – Haematology departement HUG 26