Paramus, N.J. – – September 15, 2026 -- A prespecified secondary analysis of the landmark FIBRES trial found that Octapharma's fibryga (fibrinogen [human]) cut 24-hour allogeneic blood-product transfusion requirements by 19% versus cryoprecipitate in two overlapping patient subgroups, according to findings published in the Journal of Cardiothoracic and Vascular Anesthesia.
Non-critical and elective surgery patients showed the sharpest transfusion reductions
Among 634 patients classified as non-critical before surgery -- 86% of the primary trial population -- those receiving fibryga required 13.6 blood-product units on average versus 16.2 units for cryoprecipitate recipients, a 19% relative reduction. In the 466-patient elective-surgery subgroup, representing 63% of the primary population, fibryga patients received 11.7 units compared with 14.4 units for cryoprecipitate, matching the 19% relative reduction.
Adverse events were lower among fibryga recipients in the elective-surgery group
Across the full study population, 66.7% of fibryga patients experienced treatment-emergent adverse events versus 72.7% of cryoprecipitate patients (relative risk 0.92, P=0.07). Within the elective-surgery subgroup specifically, adverse events occurred less frequently with fibryga (relative risk 0.85, P=0.02), and serious adverse events were also reduced (relative risk 0.71, P=0.04). No adverse events, serious adverse events, or deaths in the trial were deemed possibly or probably related to either treatment.
Secondary results do not alter the trial's original non-inferiority conclusion
The FIBRES trial, published in JAMA and supporting fibryga's FDA approval for acquired fibrinogen deficiency, enrolled 827 patients across 11 Canadian hospitals, with 735 included in the primary analysis. In that overall population, mean blood-component units administered were 16.3 with fibryga versus 17.0 with cryoprecipitate, meeting the prespecified non-inferiority threshold (P0.001) though not reaching statistical superiority (P=0.50). Justyna Bartoszko, lead author of the subgroup analysis, said the findings offer additional guidance on fibrinogen replacement for cardiac surgery patients with clinically significant bleeding and acquired hypofibrinogenemia.
Huub Kreuwel, Octapharma USA's Vice President of Medical Affairs, said the subgroup data could inform institutional patient blood management protocols even as the trial's primary conclusions remain unchanged. The company noted the safety findings should not be interpreted as establishing an overall safety advantage and should be assessed against fibryga's current U.S. prescribing information.