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

• Conditions: Coagulation and Hemorrhagic Disorders; Extracorporeal Membrane Oxygenation Complication

• Registration Number: NCT03642912
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2019-01-16
• Primary Completion: 2020-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
platelet function parameter	one week after ending ECMO therapy	platelet function test
coagulation parameter	one week after ending ECMO therapy	thromboelastometric test

Secondary Outcome Measures

Name	Time	Method
inflammatory parameter	one week after ending ECMO therapy	bradykinin levels

Trial Locations

Locations (1)

Department of Anesthesiology, LMU Munich; 🇩🇪 Munich, Germany