CompletedPhase 3

Prothrombin Complex Concentrate for Anticoagulant Reversal

Austria, Germany40 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rapid reversal of anticoagulatory effect

Trial details

NCT IDNCT00168077

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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