Title: Plasma FFP Evidence based usage
1Plasma (FFP) Evidence based usage
- Jed B. Gorlin MD, MBA
- Memorial Blood Centers
- AABB-Jeddah Saudi Arabia 4/09
2Goals and Objectives
- Review AABB TRALI guideline and update
- Review evidence based medicine ordering
guidelines - Discuss studies of plasma usage
- Discuss use and abuse of plasma
3Transfusion Recipient Fatalities 03-08-FDA
4TRALI
- Popovsky and Moore, 1985, 36 cases
- Respiratory distress
- Hypoxemia
- Hypotension
- Within 16 hrs (usually within 12 hrs after
transfusion of plasma containing blood components - Mechanical ventilation 72
- Rapid resolution within 96 hrs 81
- Mortality 6
5Consensus Statement
TRALI is a clinical diagnosis
From Kleinman S et al. Toward an understanding
of transfusion-related acute lung injury
statement of a consensus panel. Transfusion.
2004441774-89.
6Pathogenesis
- Priming and activation Neutrophils
- Passive transfusion of donor Antibodies of HLA
Class I II/Granulocyte Antibodies 90 of the
cases - Anti-granulocyte antibodies in the recipient
(10) - Lipid breakdown products in the blood product
- Complement activation, release neutrophil enzymes
- Damage endothelial lining
- Pulmonary edema (exudate)
7Gajic O, Moore SB. Mayo Clin Proc. 200580766
8Transfusion Related Acute Lung Injury (TRALI)
Who Is at Risk?
- Male Female 11
- No age predilection
- No disease or diagnosis predilection
- No medication pattern
CP1155325-49
9Laboratory Testing
- Donor testing
- HLA class I II and HNA antibodies
- Broad screening test and then antibody ID
- Recipient testing
- HLA class I II typing
- neutrophil typing, if possible
- If antibody is found, perform cross--match
(recipient cells and donor serum) - Recipient antigen testing or crossmatch is
necessary to implicate a donor
10UK-SHOT TRALI
- UK hemovigilance reporting-Serious hazards of
transfusion (SHOT) on-line reporting 1999-2005 - Risk-high plasma (FFP, Platelets) 175,000
- Low cryo, RBC 1500,000-gt1,000,000
- All cases investigated including both male and
female donors. Only female donors with antibodies
against patient antigens were implicated. - UK SHOT conclusion Femme Fatale!
11UK-NBS National Blood Service
- Avoid additional questions label M, F
- Implemented male only plasma 2004 but no
inventory replacement-note some US imported - Marked reduction in incidence of plasma
associated TRALI noted from 2005-7. - Recent reports up, but deaths still down
- (Platelets in UK are most derived from whole
blood using the buffy coat method. They are
pooled but then resuspended in male plasma)
12AABB TRALI guidance-Nov 06
- Blood Centers must provide reduced risk (for
TRALI) products - 11/07-Must have implemented strategy to reduce
TRALI from plasma - 11/08-Platelet strategy
- Not specific about what strategy
- Hospitals Use evidenced-based medicine
transfusion guidelines Reduce the Use - Improve reporting of severe adverse events (SAE)
13Relative risk of components
- HIGH
- FFP from whole blood or apheresis
- FP-24
- Plasma, Cryoprecipitate reduced
- Apheresis platelets
- Whole blood
- LOWER
- Red Blood Cells from whole blood or apheresis
- Platelets prepared from whole blood
- Cryoprecipitate
14Testing for WBC antibodies
15Approach to whole blood plasma
- Plasma-Whole blood-
- Divert female plasma from A, B, O donors to
recovered plasma, selectively use male plasma for
FFP (or 24hour FP)-done June 2007 - Ability to do this is predicated upon RBCPlasma
usage gt 31 (Note some RBC are collected as 2
unit collections and need to have reserves for
inventory management)
16AABB TRALI guidance
- 11/07-Must have implemented strategy to reduce
TRALI from plasma - Most centers using male whole blood plasma
- 11/08-Platelet strategy may screen for HLA
antibodies in apheresis platelets (or AB plasma) - Ordering practitioners should be using evidenced
based guidelines Reduce the Use - Improve reporting of Severe Adverse Events
- Revised guideline requires some intervention, not
full implementation by target date
17Transfusion Guidelines
- The purpose of quality assurance is to maximize
patient care and minimize risk. - The most risk-free transfusion is the one never
given. Hence, eliminating unnecessary
transfusions yields many benefits - Minimize risks from transfusion
- Economic savings
- Saves blood products for those recipients who
most need them.
18Review of FFP use
- Prevent bleeding in patients with abnormal
coagulation results who need urgent surgery or
procedure - Treat bleeding in patients with abnormal
coagulation test results - Thrombotic thrombocytopenic purpura
- Not indicated fluid resuscitation, nutrition
19AABB FFP guidance
- An evidenced based plasma transfusion guidance is
being prepared - Studies including both retrospective and
prospective are being reviewed for their level of
evidence and outcomes - Various indications, prophylactic, interventional
are being evaluated
20FFP for intervention
- Segal Transfusion (2005) 451413
- No evidence that abnormal coagulation tests
predicted bleeding with invasive procedures - Dzik The James Blundell Award Lecture 2006
transfusion and the treatment of haemorrhage
past, present and future - Transfus Med. 2007 Oct17(5)367-74.
21Lack of correlation between blood loss and coag
values
22Prospective Review
- Many transfusions occur in ER or OR where
clinical information may not be readily available
to transfusion service. - Rapidly bleeding patient may not have a low hct,
or a low hct is documented using point of care
(POC) testing, not apparent to blood bank
23Adult Plasma Guidelines
- Given to correct multiple deficiencies of plasma
coagulation factors - PT or PTT gt 1.5 times mean normal
- (Not for INRs of 1.2 or 1.3!!!!!)
- Diffuse microvascular bleeding in patient
transfused gt 1 blood volume (massive transfusion)
(but check platelets first!) - Therapeutic apheresis for TTP
24Plasma mistransfusion
- 2 units of plasma may be insufficient to correct
significant coagulopathy. Patients with INR gt2
typically need 10-15cc/kg - If fibrinogen is very low (lt50) you probably
cant transfuse enough FFP to correct
coagulopathy-you need a concentrated fibrinogen
source instead cryoprecipitate - INRs lt 1.5 rarely need correction and correction
is rarely achievable by FFP transfusion!
25MBC-HCMC- Plasma usage reduction project
26FFP transfusions volume Tx
- Transfusion (2006) 461921 Population-based audit
of fresh-frozen plasma transfusion practices
Riikka Palo et al. - Clearly, physicians order FFP in multiples of 2
instead of a more physiologic order of 10-15
ml/kg!
27TABLE 1. FFP and RBC use per 1000 population and
FFP use per 100 RBC units
Transfusion (2006) 461921 Population-based audit
of fresh-frozen plasma transfusion practices
Riikka Palo et al.
28Mean INR of Fresh Frozen Plasma (n 20 units)
Fresh frozen plasma is ineffective for correcting
minimally elevated international normalized
ratios L L. Holland, T M. Foster, R A. Marlar, J
P Brooks, Transfusion 2005 45 1234
29Change in INR after plasma transfusion
N10 within transfusions guidelines
(INRgt1.6)(open circles) N68 units outside of
guidelines, 22 Pts, 10 mL/kg (mean INR pre1.37,
post1.32)
Fresh frozen plasma is ineffective for correcting
minimally elevated international normalized
ratio. L L. Holland et al Transfusion 2005
45 1234
30Dzik . Chap 1. 2005 Mintz. Transf Ther AABB.2005
p 5
31Effect of FFP on PT in pts with mild coagulation
abnormalities
- Abdel Wahab O, Healy B, Dzik WH (Transfusion
(2006) 461279-1285 - Reviewed all cases of FFP transfusion in patients
with PT 13-17 (INR 1.1-1.85) - ONLY 0.8 of patients (N121) normalized!
- ONLY 15 achieved ½ way correction
- Median decrease was 0.2 seconds (INR0.07)
32The effect of fresh frozen plasma in severe
closed head injury
- Etemadrezaie H, Clin Neurol Neurosurg.
(2007)109166 - METHODS Double-blind randomized clinical trial.
90 patients in two parallel groups FFP or normal
saline (N/S). Severe closed head injury (GCS lt
8), no mass lesion required evacuation and no
history of coagulopathy. - RESULTS 44 FFP 46 N/S. New intracerebral
hematoma more common in the FFP (p0.012). Both
groups showed similar frequency of poor outcome
(p0.343). The mortality was significantly more
common in the FFP group than in the N/S group
(63 versus 35) CONCLUSION early empirical FFP
lead to adverse effects, including an increase in
the frequency of delayed traumatic intracerebral
hematoma and increased mortality.
33FFP in trauma
- Multiple studies both in military and civilian
trauma document correlation of better outcomes
with prevention of dilutional coagulopathy in
massive, and especially blunt trauma - Meta-analyses of trauma trials do observe trends
toward superior outcome
34Ratio of Blood Products Transfused Affects
Mortality in Patients Receiving Massive
Transfusions in Civilian Hospitals