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NCT Number: NCT03070912

Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients

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.

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Key information

Conditions

Von Willebrand Diseases Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH ARRAS, Arras, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: WITECMO-H

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2017
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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