Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Completed

• Conditions: Hemostasis

• Registration Number: NCT05128110
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients over 18 years-old
• with an atrial fibrillation
• Operated for an atrial fibrillation procedure in the University hospital of Strasbourg
• Without interruption of the direct oral anticoagulant
• For whom extended biological assessment has been made in routine practice

Exclusion Criteria

• Patients who refused the use of their data for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests	Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]

Trial Locations

Locations (1)

Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France