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

NCT02839434 | Terminated

• 1 other identifier: AGR_2015_27
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Tests

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treated with oral anticoagulants

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.

Procedure: Blood sample

Interventions

Blood sample PROCEDURE

This blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring.

Treated with oral anticoagulants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult treated with oral anticoagulant at curative dose

You may qualify if:

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

You may not qualify if:

• opposition to the patient to participate to the study

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 21, 2016
• Study Start: December 1, 2015
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: September 18, 2018

Record last verified: 2017-09

Locations

FR (1)