Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy

Terminated

• Conditions: Blood Coagulation Tests
• Interventions: Procedure: Blood sample

• Registration Number: NCT02839434
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .

Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).

The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT \> 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.

The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.

The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2017-09
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management

Exclusion Criteria

• opposition to the patient to participate to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated with oral anticoagulants	Blood sample	Ex vivo study using blood samples from patients treated with oral anticoagulant (direct oral anticoagulants or AVK) at curative dose, taken in the usual cardiac monitoring.

Primary Outcome Measures

Name	Time	Method
Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT)	1 hour

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France