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Trial record 54 of 82 for:    bleeding episodes | ( Map: France )

Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation (ECMO bleeding)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888833
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Extracorporeal Membrane Oxygenation Bleeding Complication Device: ECMO

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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation
Actual Study Start Date : April 2006
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Veno arterial extracorporeal membrane oxygenation Device: ECMO
ECMO installation




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veno arterial extracorporeal membrane oxygenation
Criteria

Inclusion Criteria: Patients over 18 years treated by peripheral veno arterial membrane oxygenation

Exclusion Criteria: None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888833


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03888833     History of Changes
Other Study ID Numbers: ELLOUZE 2019
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes