Trial intelligence / Profile preview

Beriplex P/N versus plasma for urgent reversal of vitamin K antagonist-induced coagulopathy before emergency surgery

2007-007862-39Phase 3Completed

Sponsor
CSL Limited
Start
Jan 2009
Modality
Blood Coagulation Factors → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Countries
1
01

Overview

Phase 3, randomised, open-label trial in warfarin-induced coagulopathy comparing Beriplex P/N with Plasma (2 arms). Primary endpoint: Hemostatic efficacy in preventing excessive hemorrhages during emergency surgical interventions. Started Jan 2009; status: completed.

02

Drugs

balfaxarFresh Frozen Plasma
03

Conditions

warfarin-induced coagulopathy

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