Clincosm LogoSign in Get a demo

Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

Sponsor
Aarhus University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03355625
Collaborator
University of Aarhus (Other)
33
Enrollment
2
Locations
26.9
Actual Duration (Months)
16.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy.

The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment.

    The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
    Actual Study Start Date :
    Sep 1, 2017
    Actual Primary Completion Date :
    Sep 30, 2019
    Actual Study Completion Date :
    Nov 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Changes in platelet function [Platelet function measured day 1 and day 3 on ECMO]

      Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry

    Secondary Outcome Measures

    1. Changes in platelet aggregation [Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).]

      Comparison of platelet aggregation measured by whole blood impedance aggregometry (Multiplate).

    2. Immature platelet count [Measured every morning from day 1 to day 8 on ECMO (except weekends)]

      Estimation of platelet turn-over measured by a blood analyzer (Sysmex)

    3. Platelet count [Measured every morning from day 1 to day 8 on ECMO (except weekends)]

      Estimation of platelet count measured by a blood analyzer (Sysmex)

    Eligibility Criteria

    Criteria

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

    • Treatment with veno-venous or veno-arterial ECMO

    • Age ≥18 years

    Exclusion Criteria:
    • ECMO treatment initiated post-operatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital Aarhus Denmark 8000
    2 Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • Aarhus University Hospital
    • University of Aarhus

    Investigators

    • Principal Investigator: Camilla Mains Balle, Research fellow, Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
    • Study Chair: Anne-Mette Hvas, Professor, MD, PhD, Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
    • Study Chair: Anni Nørgaard Jeppesen, MD, PhD, Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
    • Study Chair: Steffen Christensen, MD, PhD, Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT03355625
    Other Study ID Numbers:
    • ECMO-Camilla
    First Posted:
    Nov 28, 2017
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aarhus University Hospital
    Flow Cytometry
    eCPR
    Extracorporeal Life Support

    Study Results

    No Results Posted as of May 26, 2022