Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung

Conditions
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Coagulation and Hemorrhagic Disorders, Extracorporeal Membrane Oxygenation Complication

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO patients<br>ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet function parameter | platelet function test | after starting ECMO therapy - up to 28 days after starting ECMO therapy | 
| platelet function parameter | platelet function test | one week after ending ECMO therapy | 
| coagulation parameter | thromboelastometric test | after starting ECMO therapy - up to 28 days after starting ECMO therapy | 
| coagulation parameter | thromboelastometric test | one week after ending ECMO therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory parameter | bradykinin levels | after starting ECMO therapy - up to 28 days after starting ECMO therapy | 
| inflammatory parameter | bradykinin levels | one week after ending ECMO therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, haemostasis, coagulation, haemostatic alterations