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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04133844
Acronym
ATECMO
Enrollment
50
Registered
2019-10-21
Start date
2020-05-05
Completion date
2021-05-18
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Cardiac Insufficiency

Keywords

extracorporeal membrane oxygenation

Brief summary

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

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.

Interventions

BIOLOGICALBlood 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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
To study antithrombin level from during the first 24h after ECMO initiationDay 7Blood sample at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation

Secondary

MeasureTime frameDescription
To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)Day 7Blood sample
To study relationship between antithrombin level and heparin resistanceDay 7Blood sample
To study antithrombin level 24h after initialization of ECMOHour 24Blood sample at 24h
To study clinical factors associated with AT deficiencyDay 7Blood sample
To describe clinical evolution of patients according to initial AT levelHour 0Blood sample
To study relationship between antithrombin level and thrombin generation testDay 7Blood sample

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026