Reversal of oral direct factor Xa inhibitors rivaroxaban and apixaban by two different dosages of prothrombin complex concentrate (Cofact®)
- Conditions
- use of anticoagulation10047075
- Registration Number
- NL-OMON37035
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* Healthy male subjects as documented by laboratory screen tests (including HIV/HBV/HCV screening), personal medical history and normal physical examination.
* Age *18 years, < 50 years.
* No personal history of thrombotic disease/bleeding disorders.
* No significant family history of thrombotic disease/bleeding disorders, such as recurrent thrombotic/bleeding events or thrombotic/bleeding events in the absence of any risk factors.
* Able to provide written informed consent.
Exclusion criteria are:
* History of allergic reaction to blood products.
* Current participation in any other investigational drug study or within the past 30 days.
* Presence of any condition that, as judged by the investigator, would place the subject at increased risk of harm if he participated in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the reversal (normalisation) of coagulation assays, at<br /><br>the end of oral f-Xa inhibitor administration and after the infusion of PCC or<br /><br>placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>