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Completed

NCT Number: NCT04133844

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

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

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Key information

Conditions

Severe Cardiac Insufficiency Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To study antithrombin level 24h after initialization of ECMO

    Time frame: Hour 24

    Blood sample at 24h

  2. To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)

    Time frame: Day 7

    Blood sample

  3. To study relationship between antithrombin level and heparin resistance

    Time frame: Day 7

    Blood sample

  4. To study relationship between antithrombin level and thrombin generation test

    Time frame: Day 7

    Blood sample

  5. To study clinical factors associated with AT deficiency

    Time frame: Day 7

    Blood sample

  6. To describe clinical evolution of patients according to initial AT level

    Time frame: Hour 0

    Blood sample

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ATECMO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2019
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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