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ECMO PFA-100: Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

Sponsor
Rennes University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03248596
Collaborator
(none)
5
Enrollment
1
Location
5
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
    Actual Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes [Day 5]

    Eligibility Criteria

    Criteria

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

    • Patient older than 18 years old

    • Patient with ECMO

    • Patient hospitalized in an intensive care unit at the University Hospital of Rennes

    Exclusion Criteria:

    • Known history for constitutional pathology of the primary haemostasis

    • Platelets < 100000 / mm3 or hematocrit < 28 % between H+12 and H+24

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Rennes Rennes France 35033

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03248596
    Other Study ID Numbers:
    • 35RC15_3023_ECMO PFA-100
    First Posted:
    Aug 14, 2017
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Nov 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rennes University Hospital
    Extracorporeal Membrane Oxygenation (ECMO)
    Primary hemostasis

    Study Results

    No Results Posted as of Nov 21, 2017