Status:
UNKNOWN
Reversal of the Antithrombotic Action of New Oral Anticoagulants
Lead Sponsor:
Gines Escolar
Collaborating Sponsors:
Ministry of Health, Spain
Conditions:
Thrombosis
Anticoagulant-induced Bleeding
Eligibility:
All Genders
21-60 years
Phase:
PHASE4
Brief Summary
The main goal of this study is to improve safety and efficiency of clinical practice with the new generation of oral anticoagulants. 1. To determine the effect of new oral anticoagulants (dabigatran ...
Detailed Description
There is a lack of information on antidotes that could reverse the effects of new oral anticoagulants in patients that require a rapid restoration of their impaired hemostatic mechanisms. The present ...
Eligibility Criteria
Inclusion
- Healthy volunteers ages from 21 to 60 years
- Approval informed consent
Exclusion
- History of hepatic or kidney disease
- Previous history of hemorrhagic or thrombotic disease
- Pregnancy or breast feeding
- Concomitant use of drugs affecting hemostasis
- Use of medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug (according to manufacturers label)
- Practice of risky sports (during the study period)
- Blood donation in the previous 3 months
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01478282
Start Date
January 1 2012
End Date
December 1 2012
Last Update
March 12 2012
Active Locations (1)
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1
Hospital Clinic, Fundació Clinic (FCRB)
Barcelona, Barcelona, Spain, 08036