Abstract
IntroductionHaemostatic therapy in surgical and/or massive trauma patients typically involves transfusion of fresh frozen plasma (FFP). Purified human fibrinogen concentrate may offer an alternative to FFP in some instances. In this systematic review, we investigated the current evidence for the use of FFP and fibrinogen concentrate in the perioperative or massive trauma setting.MethodsStudies reporting the outcome (blood loss, transfusion requirement, length of stay, survival and plasma fibrinogen level) of FFP or fibrinogen concentrate administration to patients in a perioperative or massive trauma setting were identified in electronic databases (1995 to 2010). Studies were included regardless of type, patient age, sample size or duration of patient follow-up. Studies of patients with congenital clotting factor deficiencies or other haematological disorders were excluded. Studies were assessed for eligibility, and data were extracted and tabulated.ResultsNinety-one eligible studies (70 FFP and 21 fibrinogen concentrate) reported outcomes of interest. Few were high-quality prospective studies. Evidence for the efficacy of FFP was inconsistent across all assessed outcomes. Overall, FFP showed a positive effect for 28% of outcomes and a negative effect for 22% of outcomes. There was limited evidence that FFP reduced mortality: 50% of outcomes associated FFP with reduced mortality (typically trauma and/or massive bleeding), and 20% were associated with increased mortality (typically surgical and/or nonmassive bleeding). Five studies reported the outcome of fibrinogen concentrate versus a comparator. The evidence was consistently positive (70% of all outcomes), with no negative effects reported (0% of all outcomes). Fibrinogen concentrate was compared directly with FFP in three high-quality studies and was found to be superior for > 50% of outcomes in terms of reducing blood loss, allogeneic transfusion requirements, length of intensive care unit and hospital stay and increasing plasma fibrinogen levels. We found no fibrinogen concentrate comparator studies in patients with haemorrhage due to massive trauma, although efficacy across all assessed outcomes was reported in a number of noncomparator trauma studies.ConclusionsThe weight of evidence does not appear to support the clinical effectiveness of FFP for surgical and/or massive trauma patients and suggests it can be detrimental. Perioperatively, fibrinogen concentrate was generally associated with improved outcome measures, although more high-quality, prospective studies are required before any definitive conclusions can be drawn.
Highlights
Haemostatic therapy in surgical and/or massive trauma patients typically involves transfusion of fresh frozen plasma (FFP)
The majority (62%) of FFP studies involved the comparison of the intervention group against a different dosage, formulation or blood product
There were five fibrinogen concentrate comparator studies, two comparing fibrinogen concentrate with no fibrinogen concentrate or with a non blood product and, importantly, three studies comparing the effect of fibrinogen concentrate directly with FFP
Summary
Haemostatic therapy in surgical and/or massive trauma patients typically involves transfusion of fresh frozen plasma (FFP). We investigated the current evidence for the use of FFP and fibrinogen concentrate in the perioperative or massive trauma setting. Haemostatic therapy in patients without preexisting haemostatic disorders aims to substitute key components (clotting factors and other blood components) by transfusion of allogeneic blood products, including fresh frozen plasma (FFP), platelet concentrate (PC), packed red blood cells (RBC) and, in some countries, cryoprecipitate. FFP has been associated with increased risk of morbidity and mortality [5,6], whilst the evidence to support the effectiveness of FFP in the perioperative setting or its appropriate dosing in the massive transfusion setting has been questioned [7,8,9,10]
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