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

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03642912
• Other study ID #: LMU 18-047
• Status: Active, not recruiting
• Start date: January 16, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulation and Hemorrhagic Disorders
• Extracorporeal Membrane Oxygenation Complication
• Hemorrhagic Disorders

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, LMU Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bleeding assessment	all patients are screened for signs of bleeding or thrombosis	after starting ECMO therapy - up to 28 days after starting ECMO therapy
Other	bleeding assessment	all patients are screened for signs of bleeding or thrombosis	one week after ending ECMO therapy
Primary	platelet function parameter	platelet function test	after starting ECMO therapy - up to 28 days after starting ECMO therapy
Primary	platelet function parameter	platelet function test	one week after ending ECMO therapy
Primary	coagulation parameter	thromboelastometric test	after starting ECMO therapy - up to 28 days after starting ECMO therapy
Primary	coagulation parameter	thromboelastometric test	one week after ending ECMO therapy
Secondary	inflammatory parameter	bradykinin levels	after starting ECMO therapy - up to 28 days after starting ECMO therapy
Secondary	inflammatory parameter	bradykinin levels	one week after ending ECMO therapy