Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation

Completed

• Conditions: Bleeding; Complication; Extracorporeal Membrane Oxygenation
• Interventions: Device: ECMO

• Registration Number: NCT03888833
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2016-12
• Study Completion: 2018-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-22
• Last Update Submitted: 2019-03-22
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

Patients over 18 years treated by peripheral veno arterial membrane oxygenation

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Veno arterial extracorporeal membrane oxygenation	ECMO	-

Primary Outcome Measures

Name	Time	Method
Rate of major hemorrhagic episodes defined as follows: loss of over 2g dl-1 of hemoglobin in 24 h, bleeding rate over 20 ml kg-1 day-1 or blood transfusion over 10 ml kg-1 day-1	Through study completion, an average of 10 years	Our main objective was to evaluate risk factors independently associated with major hemorrhagic episode. We collected patient characteristics at the start of VA ECMO: age, gender, anthropometric information, medical history and chronic treatments. We also calculated SOFA and APACHE II scores on the day of VA ECMO implementation. We noted the indication for VA ECMO, any pre-cannulation treatments (fibrinolysis, aspirin, heparin), where VA ECMO was inserted and whether or not an intra-aortic balloon pump was present. With regard to various complications, we collected the quantity of delivered blood products , the site of bleeding initial temperature. The biological data were collected at initiation of VA ECMO.

Secondary Outcome Measures

Name	Time	Method
Rate of mortality	30 day
Length of stay	Through study completion, an average of 10 years
Duration of life support	Through study completion, an average of 10 years
Ischemic and thrombotic complications	Through study completion, an average of 10 years

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France