Fixed-dose 4F-PCC safe, effective for FXal reversal in non-neurologic bleeds

A fixed-dose four-factor prothrombin complex concentrate (4F-PCC) demonstrates both safety and efficacy for factor Xa inhibitor (FXal) reversal in patients with non-neurologic haemorrhage, according to a recent study.

Fifty-nine patients presenting with a non-neurologic haemorrhage were enrolled in this study. Of these, 30 were in the fixed-dose group and 29 in the weight-based group. The rate of hemostatic efficacy did not significantly differ between the two dose groups (93.3 percent vs 93.1 percent; p=1).

“This study adds to current evidence suggesting that a fixed-dose 4F-PCC is both safe and efficacious for FXaI reversal in non-neurologic bleeds,” the authors said.

This multicentre, retrospective chart review was carried out from 21 January 2020 to 21 January 2022 and included patients aged ≥18 years who had received one dose of 4F-PCC for FXal reversal for a non-neurologic bleed.

Hemostatic efficacy was defined as the absence of haemorrhagic progression confirmed with imaging, >2 g/dl decrease in Hgb within 6 h or 4F-PCC administration, reports of further significant bleeding in chart note documentation within 48 h, and a maintained or increased anti-factor Xa level from baseline.

“There is a growing body of evidence to support that utilizing fixed dose vs weight-based dosing of 4F-PCC for FXaI reversal is safe and efficacious,” the authors noted.