Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation
ECMO bleeding
Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation
1 other identifier
observational
278
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedFebruary 3, 2026
January 1, 2026
10.7 years
March 21, 2019
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Through study completion, an average of 10 years
Secondary Outcomes (4)
Rate of mortality
30 day
Duration of life support
Through study completion, an average of 10 years
Length of stay
Through study completion, an average of 10 years
Ischemic and thrombotic complications
Through study completion, an average of 10 years
Study Arms (1)
Veno arterial extracorporeal membrane oxygenation
Interventions
Eligibility Criteria
Veno arterial extracorporeal membrane oxygenation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21079, France
Related Publications (1)
Ellouze O, Abbad X, Constandache T, Missaoui A, Berthoud V, Daily T, Aho S, Bouchot O, Bouhemad B, Guinot PG. Risk Factors of Bleeding in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. Ann Thorac Surg. 2021 Feb;111(2):623-628. doi: 10.1016/j.athoracsur.2020.02.012. Epub 2020 Mar 12.
PMID: 32171730RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
April 1, 2006
Primary Completion
December 1, 2016
Study Completion
January 1, 2018
Last Updated
February 3, 2026
Record last verified: 2026-01