Coagulation factor concentrates (CFC) are more effective than fresh frozen plasma (FFP) for reversing trauma-induced coagulopathy, according to a new randomized trial.
“Our results underline the importance of early fibrinogen supplementation for severe clotting failure in multiple trauma,” Dr. Petra Innerhofer of the Medical University of Innsbruck in Austria and colleagues write. “A CFC-based algorithm guided by viscoelastic tests is considerably superior to FFP transfusion.”
There has been “great uncertainty” about whether FFP or CFC, or a combination of the two, should be used to treat trauma-induced coagulopathy, Dr. Innerhofer and her colleagues note in their report, published online April 28 in The Lancet Haematology.
The researchers randomly assigned 100 trauma patients with Injury Severity Score (ISS) above 15 to receive CFC or FFP, 94 of whom were included in the modified intention-to-treat analysis. In per-protocol analysis, they compared outcomes in 48 patients treated with CFC only, 23 who received FFP and rescue therapy, and 21 given FFP only.
The trial was halted early when interim analysis showed patients with FFP were at increased risk of failing treatment and requiring massive transfusion.
Fifty-two percent of the FFP group required rescue treatment, compared to 4 percent of the CFC group (odds ratio, 25.34; P<0.0001); similarly, 30 percent of the FFP group required massive transfusion versus 12 percent of the CFC group (OR, 3.04; P=0.042). Two-thirds of the FFP group had multiple-organ failure, while half of the FFP group did (OR 1.92; P=0.15). A post hoc analysis adjusted for ISS and brain injury found that the risk of multiple-organ failure was significantly higher with FFP (OR, 3.13).
“Persistent low fibrin polymerisation due to uncorrected hypofibrinogenaemia leads to poor clot strength, which results in prolonged bleeding, increased transfusion requirements, massive transfusion, and ultimately increased risk for multiple organ failure,” Dr. Innerhofer and her colleagues write. “Considering all the published data and our data, we suggest that the recommendation for first-line FFP transfusion be critically reassessed towards a goal-directed therapy focusing on early and effective fibrinogen replacement.”
In an editorial accompanying the study, Dr. Oliver Grottke and Dr. Rolf Rossaint of RWTH Aachen University Hospital in Germany write, “Randomised controlled trials in this field are challenging to do, and the authors of the RETIC study should be praised for successfully undertaking their study without technical difficulties. The RETIC study represents an important step in our knowledge of how best to approach coagulation management in trauma. Further data from well designed randomised controlled trials are clearly needed to show the benefits and risks of thromboelastometry-guided coagulation factor therapy.”