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Completed

NCT Number: NCT03888833

Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation

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

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Key information

Conditions

Extracorporeal Membrane Oxygenation Bleeding Complication Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients over 18 years treated by peripheral veno arterial membrane oxygenation

Exclusion criteria

None

Treatment and study plan

ECMO

Device

ECMO installation

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

    Time frame: 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 outcomes

  1. Rate of mortality

    Time frame: 30 day

  2. Duration of life support

    Time frame: Through study completion, an average of 10 years

  3. Length of stay

    Time frame: Through study completion, an average of 10 years

  4. Ischemic and thrombotic complications

    Time frame: Through study completion, an average of 10 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation

Acronym: ECMO bleeding

Important dates

Study start
2006
Primary completion
2016
Study completion
2018
First posted
Mar 25, 2019
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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