Clinical trial NCT03642912: Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)
Official title: Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulation and Hemorrhagic Disorders
Extracorporeal Membrane Oxygenation Complication
Keywords: ECMO
haemostasis
coagulation
haemostatic alterations
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients treated with ECMO

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.

Eligibility criteria: 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

Primary outcomes:
measure: platelet function parameter
timeFrame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
measure: platelet function parameter
timeFrame: one week after ending ECMO therapy
measure: coagulation parameter
timeFrame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
measure: coagulation parameter
timeFrame: one week after ending ECMO therapy
Secondary outcomes:
measure: inflammatory parameter
timeFrame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
measure: inflammatory parameter
timeFrame: one week after ending ECMO therapy
Other outcomes:
measure: bleeding assessment
timeFrame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
measure: bleeding assessment
timeFrame: one week after ending ECMO therapy
Locations:
city: Munich
country: Germany
facility: Department of Anesthesiology, LMU Munich
Study officials:
affiliation: Department of Anaesthesiology, LMU Munich
name: Michael Zoller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Laboratory Medicine, LMU Munich
name: Mathias Bruegel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, LMU Munich
name: Dominik J Hoechter, MD
role: STUDY_DIRECTOR
affiliation: Institute of Laboratory Medicine, LMU Munich
name: Michael Weigand, MD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology, LMU Munich
name: Bernhard Zwißler, MD, Prof.
role: STUDY_CHAIR
affiliation: Institute of Laboratory Medicine, LMU Munich
name: Daniel Teupser, MD, Prof.
role: STUDY_CHAIR
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