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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: University Hospital, Lille

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: February 13, 2017
Date Started: June 2017
Date Completion: May 2020
Last Updated: February 28, 2017
Last Verified: February 2017