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

NCT03642912 | Unknown DMC

• 1 other identifier: LMU 18-047
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation and Hemorrhagic Disorders; Extracorporeal Membrane Oxygenation Complication

Keywords

ECMO; haemostasis; coagulation; haemostatic alterations

Outcome Measures

Primary Outcomes (4)

• platelet function parameter

  platelet function test

  after starting ECMO therapy - up to 28 days after starting ECMO therapy

• platelet function parameter

  platelet function test

  one week after ending ECMO therapy

• coagulation parameter

  thromboelastometric test

  after starting ECMO therapy - up to 28 days after starting ECMO therapy

• coagulation parameter

  thromboelastometric test

  one week after ending ECMO therapy

Secondary Outcomes (2)

• inflammatory parameter

  after starting ECMO therapy - up to 28 days after starting ECMO therapy

• inflammatory parameter

  one week after ending ECMO therapy

Other Outcomes (2)

• bleeding assessment

  after starting ECMO therapy - up to 28 days after starting ECMO therapy

• bleeding assessment

  one week after ending ECMO therapy

Study Arms (1)

ECMO patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients treated with ECMO

You may qualify if:

• patient treated on ICU of Department of Anesthesiology of LMU Munich
• treated with ECMO
• age \>/= 18 years (adult patients only)
• informed consent

You may not qualify if:

• underage patients
• pregnant patients
• hemoglobin level \< 8mg/dl

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Anesthesiology, LMU Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Thrombosis; Hemorrhagic Disorders

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michael Zoller, MD

  Department of Anaesthesiology, LMU Munich

  PRINCIPAL INVESTIGATOR

• Mathias Bruegel, MD

  Institute of Laboratory Medicine, LMU Munich

  PRINCIPAL INVESTIGATOR

• Dominik J Hoechter, MD

  Department of Anaesthesiology, LMU Munich

  STUDY DIRECTOR

• Michael Weigand, MD

  Institute of Laboratory Medicine, LMU Munich

  STUDY DIRECTOR

• Bernhard Zwißler, MD, Prof.

  Department of Anaesthesiology, LMU Munich

  STUDY CHAIR

• Daniel Teupser, MD, Prof.

  Institute of Laboratory Medicine, LMU Munich

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 22, 2018
• Study Start: January 16, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)