Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation

Completed

• Conditions: Severe Cardiac Insufficiency

• Registration Number: NCT04133844
• Lead Sponsor: Rennes University Hospital

Brief Summary

Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

Detailed Description

Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2020-05-05
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
• Patients who have not expressed opposition to participate

Exclusion Criteria

• Arterial thrombosis or progressive venous thrombosis
• Contraindication to heparin
• Constitutional deficiency in antithrombin
• Patient refusal
• Minor patient
• Protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study antithrombin level from during the first 24h after ECMO initiation	Day 7	Blood sample at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation

Secondary Outcome Measures

Name	Time	Method
To study relationship between antithrombin level and heparin resistance	Day 7	Blood sample
To study antithrombin level 24h after initialization of ECMO	Hour 24	Blood sample at 24h
To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)	Day 7	Blood sample
To study relationship between antithrombin level and thrombin generation test	Day 7	Blood sample
To describe clinical evolution of patients according to initial AT level	Hour 0	Blood sample
To study clinical factors associated with AT deficiency	Day 7	Blood sample

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France