NCT04133844

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

May 5, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

October 17, 2019

Last Update Submit

June 3, 2021

Conditions

Severe Cardiac Insufficiency

Keywords

extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • To study antithrombin level 24h after initialization of ECMO

    Hour 24

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

    Day 7

  • To study relationship between antithrombin level and heparin resistance

    Day 7

  • To study relationship between antithrombin level and thrombin generation test

    Day 7

  • To study clinical factors associated with AT deficiency

    Day 7

  • +1 more secondary outcomes

Study Arms (1)

Extracorporeal membrane oxygenation

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

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

Extracorporeal membrane oxygenation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)

You may qualify if:

  • Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
  • Patients who have not expressed opposition to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

May 5, 2020

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Locations

FR(1)