- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03642912
Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)
Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung
Study Overview
Status
Detailed Description
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich. Adult ECMO patients are included in the study after informed consent.
Bleeding and thromboembolic complications as well as treatment details are recorded. Additional coagulation laboratory markers (such as von-Willebrand-factor, ADAMTS13-protease, platelet function tests and thromboelastometric tests) are correlated with clinical signs of bleeding. Regular ultrasound examination of the large vessels are performed to Screen for thrombosis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Munich, Germany, 81377
- Department of Anesthesiology, LMU Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient treated on ICU of Department of Anesthesiology of LMU Munich
- treated with ECMO
- age >/= 18 years (adult patients only)
- informed consent
Exclusion Criteria:
- underage patients
- pregnant patients
- hemoglobin level < 8mg/dl
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ECMO patients
ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
platelet function parameter
Time Frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
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platelet function test
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after starting ECMO therapy - up to 28 days after starting ECMO therapy
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platelet function parameter
Time Frame: one week after ending ECMO therapy
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platelet function test
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one week after ending ECMO therapy
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coagulation parameter
Time Frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
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thromboelastometric test
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after starting ECMO therapy - up to 28 days after starting ECMO therapy
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coagulation parameter
Time Frame: one week after ending ECMO therapy
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thromboelastometric test
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one week after ending ECMO therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory parameter
Time Frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
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bradykinin levels
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after starting ECMO therapy - up to 28 days after starting ECMO therapy
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inflammatory parameter
Time Frame: one week after ending ECMO therapy
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bradykinin levels
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one week after ending ECMO therapy
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding assessment
Time Frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
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all patients are screened for signs of bleeding or thrombosis
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after starting ECMO therapy - up to 28 days after starting ECMO therapy
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bleeding assessment
Time Frame: one week after ending ECMO therapy
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all patients are screened for signs of bleeding or thrombosis
|
one week after ending ECMO therapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Zoller, MD, Department of Anaesthesiology, LMU Munich
- Principal Investigator: Mathias Bruegel, MD, Institute of Laboratory Medicine, LMU Munich
- Study Director: Dominik J Hoechter, MD, Department of Anaesthesiology, LMU Munich
- Study Director: Michael Weigand, MD, Institute of Laboratory Medicine, LMU Munich
- Study Chair: Bernhard Zwißler, MD, Prof., Department of Anaesthesiology, LMU Munich
- Study Chair: Daniel Teupser, MD, Prof., Institute of Laboratory Medicine, LMU Munich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMU 18-047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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