This study evaluates the efficacy, safety and tolerance of Beriplex® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR because of emergency surgery. The primary objectives are to prevent excessive hemorrhages during urgent surgical procedures and to reduce pre-operative INR values at 30 minutes after end of infusion.
The estimated study enrollment is 176 from approximately 30 sites in the United States and 30 sites around the world. The Reading Hospital is currently enrolling patients in this study, which is expected to remain open until December 2011.
For more information, please call the Clinical Trials Office at 610-988-4308 or visit clinicaltrials.gov.