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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03642912

Enrollment

Registered

2018-08-22

Start date

2019-01-16

Completion date

2022-12-31

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation and Hemorrhagic Disorders, Extracorporeal Membrane Oxygenation Complication

Keywords

ECMO, haemostasis, coagulation, haemostatic alterations

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
platelet function parameter	after starting ECMO therapy - up to 28 days after starting ECMO therapy	platelet function test
coagulation parameter	after starting ECMO therapy - up to 28 days after starting ECMO therapy	thromboelastometric test

Secondary

Measure	Time frame	Description
inflammatory parameter	after starting ECMO therapy - up to 28 days after starting ECMO therapy	bradykinin levels

Other

Measure	Time frame	Description
bleeding assessment	after starting ECMO therapy - up to 28 days after starting ECMO therapy	all patients are screened for signs of bleeding or thrombosis

Countries

Germany

Outcome results