Abstract Number: VPB0996
Meeting: ISTH 2022 Congress
Background: Acquired fibrinogen deficiency and impaired thrombin generation are major drivers of acute traumatic coagulopathy (ATC), which coupled with bleeding is a leading cause of in-hospital mortality in trauma patients. Early administration of clotting factor concentrates (fibrinogen concentrate [FC], prothrombin complex concentrate [PCC]) may be superior to the current standard of care (SOC); ratio-based plasma resuscitation via a massive hemorrhage protocol (MHP).
Aims: To examine whether early administration of FC+PCC is superior to the current SOC in bleeding trauma patients.
Methods: FiiRST-2 is a randomized, parallel-control, superiority trial with a two-armed, two stage design and adaptive interim analysis performed across 11 Canadian Level I trauma centers (funded by Octapharma). Bleeding trauma patients >16 years old (Nf350) will receive FC+PCC (intervention) or 4 units of red blood cells (RBC):plasma (control), plus platelets, until the second MHP pack has been given, MHP is terminated once bleeding has stopped, or 24 h has elapsed from admission (Figure 1). Exclusion criteria include receipt of >2 units RBCs before randomization, >3 h elapsed from injury, catastrophic brain injury, or known bleeding disorders. The primary endpoint is superiority in the number of composite allogeneic blood product units transfused within 24 h after administration. Secondary efficacy endpoints include RBC units transfused within the first 24 h following admission, ventilator-free days, and 28 day all-cause mortality. All adverse and serious adverse events will be assessed through 28 days.
Results: FiiRST-2 has enrolled 60 patients at 4 sites to date. An interim analysis will be performed once 120 patients have completed the study. Completion is expected in Q1 2023.
Conclusion(s): This study will determine whether early use of coagulation factor concentrates (FC+PCC) is superior to the current SOC in bleeding trauma patients, potentially having an impact on clinical practice by improving management and outcomes for this high-risk patient population.
To cite this abstract in AMA style:Da Luz L, Callum J, Beckett A, Peng H, Engels P, Parry N, Tien H, Nathens A, Carroll J, Grewal D, Karkouti K. FiiRST-2; a prospective, randomized study of clotting factor concentrates versus standard massive hemorrhage protocol in severely bleeding trauma patients [abstract]. https://abstracts.isth.org/abstract/fiirst-2-a-prospective-randomized-study-of-clotting-factor-concentrates-versus-standard-massive-hemorrhage-protocol-in-severely-bleeding-trauma-patients/. Accessed August 16, 2022.
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