- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03248596
Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO) (ECMO PFA-100)
November 17, 2017 updated by: Rennes University Hospital
The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.
Study Overview
Status
Terminated
Conditions
Detailed Description
The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary.
The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rennes, France, 35033
- CHU de Rennes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with ECMO
Description
Inclusion Criteria:
- Patient older than 18 years old
- Patient with ECMO
- Patient hospitalized in an intensive care unit at the University Hospital of Rennes
Exclusion Criteria:
- Known history for constitutional pathology of the primary haemostasis
- Platelets < 100000 / mm3 or hematocrit < 28 % between H+12 and H+24
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes
Time Frame: Day 5
|
Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
August 9, 2017
First Submitted That Met QC Criteria
August 9, 2017
First Posted (Actual)
August 14, 2017
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 35RC15_3023_ECMO PFA-100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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