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

Severe Cardiac Insufficiency Clinical Trial

— ATECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133844
• Other study ID #: 35RC19_9727_ATECMO
• Status: Completed
• Start date: May 5, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: June 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antithrombin III Deficiency
• Heart Failure
• Severe Cardiac Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study antithrombin level from during the first 24h after ECMO initiation	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	To study antithrombin level 24h after initialization of ECMO	Blood sample at 24h	Hour 24
Secondary	To study the prevalence of antithrombin (AT) deficiency (=70%) at each time point (from H0 to day 7)	Blood sample	Day 7
Secondary	To study relationship between antithrombin level and heparin resistance	Blood sample	Day 7
Secondary	To study relationship between antithrombin level and thrombin generation test	Blood sample	Day 7
Secondary	To study clinical factors associated with AT deficiency	Blood sample	Day 7
Secondary	To describe clinical evolution of patients according to initial AT level	Blood sample	Hour 0