Prothrombin Complex Concentrate for Anticoagulant Reversal

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Anticoagulants; Thrombin

Criteria

Key Inclusion Criteria:

• Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery

• INR > 2 at baseline

Key Exclusion Criteria:

• Acute thromboembolic event

• Treatment with any other investigational drug in the last 30 days before study entry

• Less than 2 weeks of stable oral anticoagulation