Superiority of Fibrinogen Concentrate Versus Cryoprecipitate for Treatment of Bleeding in Cardiac Surgery Patients: A Secondary Analysis of the FIBRES Randomized Clinical Trial Stratified by Surgical Risk.

In 30 seconds

This secondary analysis of the multicentre FIBRES randomized trial compared fibrinogen concentrate (FC) with cryoprecipitate for postbypass bleeding in adults with acquired hypofibrinogenemia after cardiac surgery. Among 735 patients, FC was superior for reducing cumulative red-cell, platelet and plasma use in prespecified subgroups: non-critically ill patients received a mean 13.6 versus 16.2 units (mean ratio 0.84 [95% CI 0.73, 0.96]; p = 0.01), and elective-surgery patients received 11.7 versus 14.4 units (0.81 [0.69, 0.96]; p = 0.02). In elective patients, adverse events were also less frequent with FC.

Key findings

• Among non-critically ill patients, mean blood-component use was 13.6 with FC versus 16.2 units with cryoprecipitate (mean ratio 0.84 [95% CI 0.73, 0.96]; p = 0.01).
• Among elective-surgery patients, mean blood-component use was 11.7 versus 14.4 units (0.81 [0.69, 0.96]; p = 0.02) with FC and cryoprecipitate, respectively.
• In elective-surgery patients, adverse events (relative risk 0.85 [0.75, 0.97]; p = 0.02) and serious adverse events (0.71 [0.52, 0.99]; p = 0.04) were less frequent with FC.

Why it matters

Postbypass bleeding with acquired hypofibrinogenemia can require substantial blood-component support. This analysis suggests FC may reduce component use compared with cryoprecipitate in elective and non-critically ill cardiac surgery patients, with fewer adverse events also observed in the elective subgroup. These findings help clarify which patient groups showed a benefit in this randomized-trial analysis.

What to keep in mind

This was a secondary analysis of the FIBRES trial, and the reported superiority findings apply to prespecified subgroups rather than establishing superiority across all patients.