NCT04912336

Brief Summary

To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO. (ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

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

May 6, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

May 6, 2021

Last Update Submit

July 29, 2024

Conditions

Bleeding DisorderExtra Corporeal Life SupportThrombosis

Outcome Measures

Primary Outcomes (1)

  • Thrombocytopenia

    Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients

    48 hours

Secondary Outcomes (5)

  • Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria

    48 hours

  • Clotting problems

    48 hours

  • Need for transfusion

    48 hours

  • Change in visco-elastic testing

    At 2 hours, 24 hours, 48 hours

  • Survival

    1 year

Study Arms (2)

VV-ECMO

Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.

Diagnostic Test: Standard coagulation profileDiagnostic Test: Specific coagulation testsOther: Bleeding Scores

VA-ECMO

Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.

Diagnostic Test: Standard coagulation profileDiagnostic Test: Specific coagulation testsOther: Bleeding Scores

Interventions

Standard coagulation profileDIAGNOSTIC_TEST

prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount

VA-ECMOVV-ECMO
Specific coagulation testsDIAGNOSTIC_TEST

AT III, anti Xa, ACT, ROTEM

VA-ECMOVV-ECMO
Bleeding ScoresOTHER

Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)

VA-ECMOVV-ECMO

Eligibility Criteria

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

* GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period * GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period

You may qualify if:

  • GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period
  • GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
  • ≥ 18 years
  • Signed Informed Consent, signed by subject or authorized representative

You may not qualify if:

  • Expected survival \<48-h Known coagulopathy Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Charleroi

Lodelinsart, Henegouwen, 6042, Belgium

Location

CHU UCL Namur- Godinne

Yvoir, Namen, 5530, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

University Hospital Brussels

Jette, 1090, Belgium

Location

Centre Hospitalier Universitaire Liege

Liège, 4000, Belgium

Location

University Hospital Münster

Münster, 48149, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests for coagulation parameters

MeSH Terms

Conditions

Hemostatic DisordersThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and Thrombosis

Study Officials

  • Harlinde Peperstraete, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 6, 2021

First Posted

June 3, 2021

Study Start

May 28, 2021

Primary Completion

January 16, 2023

Study Completion

April 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

DE(1)BE(5)