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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03070912
Other study ID # 2015_83
Secondary ID 2017-A00256-47
Status Recruiting
Phase
First received
Last updated
Start date January 19, 2018
Est. completion date May 2026

Study information

Verified date February 2023
Source University Hospital, Lille
Contact Antoine RAUCH, MD,PhD
Phone 320445962 (poste 29673)
Email antoine.rauch@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 418
Est. completion date May 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CH ARRAS Arras
France CH Boulogne Boulogne-sur-Mer
France CH DOUAI Douai
France CH Dunkerque Dunkerque
France Hôpital Cardiologie, CHU Lille
France Ch Tourcoing Tourcoing
France Ch Valenciennes Valenciennes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of major bleeding Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO During ECMO support, up to 3 weeks after implantation
Secondary Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO) Willebrand Factor abnormalities according to the type of ECMO support (VA- or VV-ECMO) 1 hour, 24 hours and day seven after implantation
Secondary Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO During ECMO support, up to 3 weeks after implantation
Secondary 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 Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO During ECMO support, up to 3 weeks after implantation
Secondary Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate Willebrand Factor abnormalities according major bleeding events under VA-ECMO During ECMO support, up to 3 weeks after implantation
Secondary 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 Willebrand Factor abnormalities according major bleeding events under VA-ECMO During ECMO support, up to 3 weeks after implantation
Secondary Frequency of major bleeding events according to diabetes status Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO in patients with and without diabetes During ECMO support, up to 3 weeks after implantation
Secondary Frequency of major thrombotic events according to diabetes status 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 During ECMO support, up to 3 weeks after implantation
Secondary Frequency of pro-thrombotic biological abnormalities Measurement of plasma free hemoglobin, leuco-platelet aggregates and neutrophil extracellular traps levels During ECMO support, up to 3 weeks after implantation
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