Clinical trial NCT03070912: Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Von Willebrand Diseases
Keywords: mechanical circulatory support
bleeding, acquired von willebrand disease
acquired von willebrand disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Frequency of major bleeding
timeFrame: During ECMO support, up to 3 weeks after implantation
Secondary outcomes:
measure: Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO)
timeFrame: 1 hour, 24 hours and day seven after implantation
measure: Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: 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
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: 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
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: Frequency of major bleeding events according to diabetes status
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: Frequency of major thrombotic events according to diabetes status
timeFrame: During ECMO support, up to 3 weeks after implantation
measure: Frequency of pro-thrombotic biological abnormalities
timeFrame: During ECMO support, up to 3 weeks after implantation
Other outcomes:
Locations:
city: Arras
country: France
facility: CH ARRAS
city: Boulogne-sur-Mer
country: France
facility: CH Boulogne
city: Douai
country: France
facility: CH DOUAI
city: Dunkerque
country: France
facility: CH Dunkerque
city: Lille
country: France
facility: Hôpital Cardiologie, CHU
city: Tourcoing
country: France
facility: Ch Tourcoing
city: Valenciennes
country: France
facility: Ch Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Antoine RAUCH, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: