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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

Tracking Information
First Submitted Date March 21, 2019
First Posted Date March 25, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date April 2006
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 22, 2019)
  • Rate of mortality [ Time Frame: 30 day ]
  • Duration of life support [ Time Frame: Through study completion, an average of 10 years ]
  • Length of stay [ Time Frame: Through study completion, an average of 10 years ]
  • Ischemic and thrombotic complications [ Time Frame: Through study completion, an average of 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation
Official Title Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Veno arterial extracorporeal membrane oxygenation
Condition
  • Extracorporeal Membrane Oxygenation
  • Bleeding
  • Complication
Intervention Device: ECMO
ECMO installation
Study Groups/Cohorts Veno arterial extracorporeal membrane oxygenation
Intervention: Device: ECMO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2019)
278
Original Actual Enrollment Same as current
Actual Study Completion Date January 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Exclusion Criteria: None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03888833
Other Study ID Numbers ELLOUZE 2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date March 2019