Hemodynamics, fluids & transfusion
Efficacy and safety of fibrinogen concentrate (BT524) in severe hemorrhage: Phase 3 subcohort analysis of the AdFIrst trial in patients undergoing cytoreductive surgery for pseudomyxoma peritonei
Primary result · Nominal exploratory pResult — go to the resultDifference −190 mL 95% CI −450 to 71Authors' conclusion
In patients undergoing CRS for PMP, these results provide supportive evidence for the hemostatic efficacy of FC, consistent with the overall trial and prior studies, with a favorable safety profile.
Study context
- Population
- Patients undergoing cytoreductive surgery (CRS) for pseudomyxoma peritonei with predicted intraoperative blood loss >2 L, single UK centrerandomized and evaluated
- Participants
- 98 patients
- Comparison
- Fibrinogen concentrate vs cryoprecipitate
- Fibrinogen concentrate (FC)n = 48
- Cryoprecipitate (Cryo)n = 50reference
- Primary endpoint
- Intraoperative blood loss, from decision to treat with trial drug until end of surgery (non-inferiority margin 150 mL)
Methodological detailssingle-centre, subcohort analysis, active-controlled, partially blinded, phase 3, non-inferiority
- Single-centre
- Subcohort analysis
- Active-controlled
- Partially blinded
- Phase 3
- Non-inferiority
Primary result
Nominal exploratory p
Difference
−190 mL
95% CI −450 to 71
P = 0.011
By group
FC vs Cryo
difference −190 mL (95% CI −450 to 71); P = 0.011
As reported in the abstract
Safety
Thromboembolic events · nominal exploratory p
P = 0.041
Other safety outcomes
- Comparable between groups
Original publication
Efficacy and safety of fibrinogen concentrate (BT524) in severe hemorrhage: Phase 3 subcohort analysis of the AdFIrst trial in patients undergoing cytoreductive surgery for pseudomyxoma peritonei. J Clin Anesth. Published 5 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →