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Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients (WITECMO-H)

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ClinicalTrials.gov Identifier: NCT03070912
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.

Condition or disease
Von Willebrand Diseases

Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Frequency of major bleeding [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO


Secondary Outcome Measures :
  1. Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO) [ Time Frame: 1 hour, 24 hours and day seven after implantation ]
    Willebrand Factor abnormalities according to the type of ECMO support (VA- or VV-ECMO)

  2. Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO

  3. Number of Participants With Abnormal VWF functional activities and multimeric profile in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO

  4. Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Willebrand Factor abnormalities according major bleeding events under VA-ECMO

  5. Number of Participants With major bleeding events (BARC classification) in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Willebrand Factor abnormalities according major bleeding events under VA-ECMO

  6. Frequency of major bleeding events according to diabetes status [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO in patients with and without diabetes

  7. Frequency of major thrombotic events according to diabetes status [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Number of major thrombotic events (stroke, transient ischemic attack, acute limb ischemia, ECMO thrombosis) occurring within the time course of support by ECMO in patients with and without diabetes

  8. Frequency of pro-thrombotic biological abnormalities [ Time Frame: During ECMO support, up to 3 weeks after implantation ]
    Measurement of plasma free hemoglobin, leuco-platelet aggregates and neutrophil extracellular traps levels



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients older than 18 years receiving either veno-arterial or even-venous ECMO and referred at Lille University Hospital
Criteria

Inclusion Criteria:

  • informed consent of patient or person in charge
  • patient supplied by an ECMO for cardiac or respiratory failure and referred to Lille University Hospital
  • patient affiliated to "french social security"

Exclusion Criteria:

  • pregnant woman
  • no consent
  • no affiliation to
  • patient affiliated to `
  • preexisting bleeding disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070912


Contacts
Contact: Antoine RAUCH, MD,PhD 320445962 (poste 29673) ext +33 antoine.rauch@chru-lille.fr
Contact: Sophie SUSEN, MD,PhD 320444216 ext +33 sophie.susen@chru-lille.fr

Locations
France
Hôpital Cardiologie, CHU Recruiting
Lille, France
Principal Investigator: Antoine Rauch, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Antoine RAUCH, MD,PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03070912     History of Changes
Other Study ID Numbers: 2015_83
2017-A00256-47 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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 University Hospital, Lille:
mechanical circulatory support
bleeding, acquired von willebrand disease
acquired von willebrand disease

Additional relevant MeSH terms:
Emergencies
Hemorrhage
Von Willebrand Diseases
Disease Attributes
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn