Per-procedural Concentration of Direct Oral Anticoagulants

Completed

• Conditions: Per-procedural Concentrations of Oral Anticoagulants

• Registration Number: NCT02643992
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration (\[DOAC\]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural \[DOAC\]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural \[DOAC\], defined as \[DOAC\] \< 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. \[DOAC\], will be measured during invasive procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• patient over 18 years-old
• undergoing invasive procedure
• treated with DOAC

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DOAC concentration	beginning of invasive procedure

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild (FOR); 🇫🇷 Paris, France