Status:
COMPLETED
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Floralis
Conditions:
Venous Thromboembolism
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among c...
Detailed Description
The management of critical situations is difficult for several reasons: * First, there is significant intra- and inter-individual variability in the pharmacokinetics of NOACs, which is further height...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Managed in view of surgery or an invasive procedure, emergency or not
- Managed and hospitalized for active bleeding
- Long-term therapy (in the indication atrial fibrillation or treatment of pulmonary embolism or deep vein thrombosis) by at least one antithrombotic agent from the following list: DABIGATRAN ETEXILATE MESYLATE or RIVAROXABAN or APIXABAN
Exclusion
- Pregnant women
- Refusal to participate in the study: listed in the non-inclusion registry
- Antithrombotics indicated for the prevention of venous thromboembolism
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1166 Patients enrolled
Trial Details
Trial ID
NCT02185027
Start Date
June 1 2013
End Date
December 1 2016
Last Update
October 6 2021
Active Locations (41)
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1
CHU Brugmann
Brussels, Belgium
2
Hôpitaux du Léman
Thonon-les-Bains, haute-Savoie, France
3
CH Agen
Agen, France
4
CHU d'Amiens
Amiens, France