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

June 3, 2021 updated by: Rennes University Hospital
Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Chu Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extracorporeal membrane oxygenation
Biological: Blood sample
Blood sample collection from a peripheral catheter at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study antithrombin level from during the first 24h after ECMO initiation
Time Frame: 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
Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Actual)

May 18, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC19_9727_ATECMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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