Reversal of oral anticoagulants rivaroxaban and apixaban, by two different dosages of prothrombin complex concentrate (Cofact®).
Completed
- Conditions
- Healthy male subjects between 18 and 50 year who have no medical history of thrombotic disease or bleeding disorders will be included in the study. They must have a normal physical examination and laboratory screen tests. They will not use any medication at least 14 days before the study days.
- Registration Number
- NL-OMON21617
- Lead Sponsor
- S. MiddeldorpAcademic Medical CenterMeibergdreef 9Amsterdams.middeldorp@amc.uva.nl
- Brief Summary
Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate: A Randomized, Placebo-Controlled, Crossover Study in Healthy Subjects.<br> Elise S. Eerenberg, MD; Pieter W. Kamphuisen, MD; Meertien K. Sijpkens, BSc; Joost C. Meijers, PhD; Harry R. Buller, MD; Marcel Levi, MD
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Healthy male subjects as documented by laboratory screen tests (including HIV/HBV/HCV screening), personal medical history and normal physical examination;
2. Age ≥18 years, < 50 years;
Exclusion Criteria
1. History of allergic reaction to blood products;
2. Current participation in any other investigational drug study or within the past 30 days;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the reversal (normalisation) of coagulation assays, at the end of oral f-Xa inhibitor administration and after the infusion of PCC or placebo.
- Secondary Outcome Measures
Name Time Method