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

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04133844
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Actual 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
• Actual Study Start Date: May 5, 2020
• Actual Primary Completion Date: May 18, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. To study antithrombin level 24h after initialization of ECMO [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) [Day 7]

   Blood sample

3. To study relationship between antithrombin level and heparin resistance [Day 7]

   Blood sample

4. To study relationship between antithrombin level and thrombin generation test [Day 7]

   Blood sample

5. To study clinical factors associated with AT deficiency [Day 7]

   Blood sample

6. To describe clinical evolution of patients according to initial AT level [Hour 0]

   Blood sample

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Rennes	Rennes		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT04133844
• Other Study ID Numbers: 35RC19_9727_ATECMO
• First Posted: Oct 21, 2019
• Last Update Posted: Jun 4, 2021
• Last Verified: Jun 1, 2021

• 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: Heart Failure; Antithrombin III Deficiency

Study Results

No Results Posted as of Jun 4, 2021