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

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ClinicalTrials.gov Identifier: NCT04133844
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment
Severe Cardiac Insufficiency Biological: Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133844


Contacts
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Contact: Isabelle Gouin-Thibault, MD 02.99.28.95.63 isabelle.gouin@chu-rennes.fr
Contact: Alexandre Mansour, Intern 06.47.53.34.16 alexandre.mansour@chu-rennes.fr

Locations
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France
CHU Rennes Not yet recruiting
Rennes, France, 35033
Contact: Isabelle Gouin-Thibault, MD    02.99.28.95.63    isabelle.gouin@chu-rennes.fr   
Contact: Alexandre Mansour, Intern    06.47.53.34.16    alexandre.mansour@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04133844     History of Changes
Other Study ID Numbers: 35RC19_9727_ATECMO
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
extracorporeal membrane oxygenation
Additional relevant MeSH terms:
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Heart Failure
Antithrombin III Deficiency
Heart Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants