Recommendation grades (A-C) and levels of evidence (Ia-IV) are defined at the end of the "Major Recommendations" field.
Specifications, Preparation, Storage and Handling of Fresh-Frozen Plasma (FFP) and Cryoprecipitate
Fresh-frozen plasma prepared from units of whole blood and from plasmaphaeresis are therapeutically equivalent in terms of haemostasis and side-effect profile (grade A recommendation, level I evidence).
Pathogen-Reduced Plasmas (PRP)
In any patient for whom PRP is being considered, the risks of hepatitis A virus (HAV) and parvovirus B19 transmission and their clinical sequelae should be weighed against the likely benefits (grade B recommendation, level II/III evidence).
Selection of FFP Packs by Blood Group
ABO Blood Group Compatibility
With regard to ABO blood groups, the first choice of FFP is that of the same ABO group as the patient. If this is not available, FFP of a different ABO group is acceptable so long as it has been shown not to possess anti-A or anti-B activity above a limit designed to detect 'high titres'. FFP of group O should only be given to O recipients (grade B recommendation, level III evidence).
Group O FFP should not be used in infants or neonates who are not group O because the relatively large volumes required can lead to passive immune haemolysis (grade B recommendation, level III evidence).
Rh Blood Group Compatibility
Fresh-frozen plasma, methylene blue and light-treated FFP (MBFFP) and solvent detergent treated FFP (SDFFP) of any Rh type may be given regardless of the Rh status of the recipient. No anti-D prophylaxis is required if Rh D-negative patients receive Rh D-positive FFP (grade B recommendation, level IIa evidence).
Thawing and Storage of Thawed Product
Storage after Thawing
After thawing, and when factor VIII replacement is not required, FFP and cryosupernatant may be stored at 4 degrees C in an approved blood storage refrigerator before administration to the patient so long as the infusion is completed within 24 hours of thawing. If delay in transfusing cryoprecipitate is unavoidable, the component should be stored at ambient temperature and used within 4 hours (grade B recommendation, level III evidence). (Recommendation was amended; see Addendum 2 in the "Companion Documents" field for information.)
Adverse Effects
Infection
Patients likely to receive multiple units of FFP, such as those with a congenital coagulopathy, should be considered for vaccination against hepatitis A and B (grade C recommendation, level IV evidence).
Clinical Indications for the Use of FFP, Cryoprecipitate and Cryosupernatant
Thrombotic Thrombocytopenic Purpura
Single volume daily plasma exchange should ideally be begun at presentation (grade A recommendation, level Ib evidence) and preferably within 24 hours of presentation (grade C recommendation, level IV). Daily plasma exchange should continue for a minimum of 2 days after remission is obtained (grade C recommendation, level IV evidence).
Reversal of Warfarin Effect
Fresh-frozen plasma should never be used for the reversal of warfarin anticoagulation when there is no evidence of severe bleeding (grade B recommendation, level IIa evidence).
Vitamin K Policies in Intensive Care Units (ICUs)
Intensive care unit patients should routinely receive vitamin K; 10 mg thrice weekly for adults and 0.3 mg per kg for children (grade B recommendation, level IIa evidence).
Liver Disease
Available evidence suggests that patients with liver disease and a prothrombin time (PT) more than 4 seconds longer than control are unlikely to benefit from FFP (grade C recommendation, level IV evidence).
Surgical Bleeding
Massive Transfusions
Whether and how much FFP should be used for treating a patient with major blood loss should be guided by timely tests of coagulation (including near-patient tests). 'Formulae' to guide replacement strategies should not be used (grade B recommendation, level IIb evidence).
Paediatric Use of FFP
Haemorrhagic Disease of the Newborn (HDN)
Management of Acute Haemorrhages, FFP
When haemorrhage due to HDN occurs, FFP (10 to 20 mL/kg) is indicated, as well as intravenous vitamin K (grade C recommendation, level IV evidence).
Prothrombin Complex Concentrate (PCC)
Although the coagulation defect in HDN may be reversed by PCC, there are no data to guide dosage in this situation (grade C recommendation, level IV evidence).
Neonates with Coagulopathy and Bleeding, or at Risk of Bleeding from an Invasive Procedure
Neonates with significant coagulopathy, and risk of bleeding or who are about to undergo an invasive procedure, should receive approximately 15 mL/kg of FFP as well as a dose of vitamin K (grade C recommendation, level IV evidence). Shortening of the prolonged clotting times is unpredictable and should be checked following administration.
Prevention of Intraventricular Haemorrhage in Preterm Infants
Routine administration of FFP to prevent periventricular haemorrhage (PVH) in preterm infants is not indicated (grade A recommendation, level IIb evidence).
Red Cell T Antigen Activation
In the absence of definitive data, each clinical unit should formulate its own policies and protocols for the investigation of any unexpected haemolysis associated with a transfusion of plasma to a baby with necrotizing enterocolitis (NEC) or a similar septic condition. A selective testing strategy and transfusion management protocol may be required (grade C recommendation, level IV evidence).
If there is a high suspicion of T-activated haemolysis, an exchange transfusion using low titre anti-T plasma and red cell products may be indicated. In this situation, administration of low anti-T titre (washed/resuspended) platelet concentrates may be indicated (grade C recommendation, level IV evidence).
Note, avoiding transfusion of plasma-containing blood components in infants with T-activated red cells may risk suboptimal treatment for patients requiring haemostasis support (grade B recommendation, level II/III evidence).
Definitions:
Statements of Evidence
Ia Evidence obtained from the meta-analysis of randomized controlled trials.
Ib Evidence obtained from at least one randomized controlled trial.
IIa Evidence obtained from at least one well-designed controlled study without randomization.
IIb Evidence obtained from at least one other type of well-designed quasi-experimental study.
III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.
IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.
Grades of Recommendations
Grade A Required at least one randomized controlled trial as part of a body literature of overall good quality and consistency addressing the specific recommendations (evidence levels Ia, Ib).
Grade B Requires the available of well conducted clinical studies but no randomized clinical trials on the topic of recommendations (evidence levels IIa, IIb, III).
Grade C Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality (evidence level IV).
