Status:

COMPLETED

Prothrombin Complex Concentrate for Anticoagulant Reversal

Lead Sponsor:

CSL Behring

Conditions:

Acquired Coagulation Factor Deficiency

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • Key
  • Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
  • INR \> 2 at baseline
  • Key

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

End Date :

November 1 2006

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00168077

Start Date

September 1 2005

End Date

November 1 2006

Last Update

February 11 2011

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Clinical Trials Registration Coordinator

Feldkirch, Austria, 6800

2

Clinical Trials Registration Coordinator

Vienna, Austria, 1090

3

Clinical Trials Registration Coordinator

Halle, Germany, 06112

4

Clinical Trials Registration Coordinator

Hanover, Germany, 30623