Factors in the Initial Resuscitation of Patients With Severe Trauma: The FiiRST-2 Randomized Clinical Trial

1. Replacing clotting factors with fibrinogen concentrate (FC) and prothrombin complex concentrate (PCC) versus frozen plasma (FP) did not lead to a significant difference in units of allogeneic blood products used, 24-hour or 28-day mortality, or safety outcomes including thromboembolic events.

Evidence Rating Level: 1 (Excellent)

Acute trauma coagulopathy is a major cause of mortality, long-term disability, and secondary complications in trauma. Massive hemorrhage protocols differ across continents, countries, and hospitals, and the benefits of using certain hemostatic agents versus others are inconclusive. In this multicenter, parallel-control, superiority randomized controlled trial, 217 patients aged ≥ 16 years requiring massive hemorrhage protocol by the criteria at participating sites within one hour of hospital admission were randomized in a 1:1 ratio to receive either FC and PCC or FP. Both groups received 4 units of red blood cells (RBCs) in both packs and 4 units of platelets in the second pack. The treatment period spanned 24 hours or after the second pack, whichever came first. There was no significant difference observed in the primary outcome: the mean 24-hour allogeneic blood product (RBC, FP, platelet) transfusions was 20.8 (95% CI, 16.7-25.9) units in the FC-PCC group and 23.8 (95% CI, 19.2-29.4) units in the FP group. There was no statistical difference between the FC-PCC and FP groups in thromboembolic events (risk difference, 7.13; 95% CI, −5.89 to 20.65; P = .37), 24-hour mortality (5 [7.6%] vs 12 [16.9%]; P = .24), or 28-day mortality (0.64 [95% CI, 0.30-1.37, P = .25]). This study showed FC and PCC were not superior to FP for initial resuscitation of patients with trauma and were not associated with a higher risk of thromboembolic events. In the absence of superiority, this study suggests favouring factor concentrates in trauma resuscitation, given its advantages over FP, namely that they are easier and faster to administer, have a longer shelf life, do not need blood grouping, and can be used in remote regions.

Click to read this study in JAMA Network Open

Image: PD

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