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

April 5, 2022 updated by: Michael Zoller MD, Ludwig-Maximilians - University of Munich

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Munich, Germany, 81377
        • Department of Anesthesiology, LMU Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

critically ill patients treated with ECMO

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ECMO patients
ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding assessment
Time Frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
all patients are screened for signs of bleeding or thrombosis
after starting ECMO therapy - up to 28 days after starting ECMO therapy
bleeding assessment
Time Frame: one week after ending ECMO therapy
all patients are screened for signs of bleeding or thrombosis
one week after ending ECMO therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Zoller, MD, Department of Anaesthesiology, LMU Munich
  • Principal Investigator: Mathias Bruegel, MD, Institute of Laboratory Medicine, LMU Munich
  • Study Director: Dominik J Hoechter, MD, Department of Anaesthesiology, LMU Munich
  • Study Director: Michael Weigand, MD, Institute of Laboratory Medicine, LMU Munich
  • Study Chair: Bernhard Zwißler, MD, Prof., Department of Anaesthesiology, LMU Munich
  • Study Chair: Daniel Teupser, MD, Prof., Institute of Laboratory Medicine, LMU Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 11, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMU 18-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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