Coagulopathy and SIRS During ECC in Intensive Care

April 28, 2021 updated by: University Hospital Tuebingen

A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients

This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The complex interplay between the various factors contributing to the ECC-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ECC systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ECC systems and intensive care units.

A better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ECC in intensive care medicine. The investigation of these phenomena in different ECC systems under clinical conditions is therefore the goal of this study.

In order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ECC systems under intensive care conditions.

Study Type

Observational

Enrollment (Actual)

65

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

  • Germany
      • Tübingen, Germany, 72076
        • Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients undergoing implantation of extracorporeal circulation or mechanical circulatory support systems (ECLS / ECMO / LVAD / dialysis) due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases.
  • Patients undergoing cardiac surgery with extracorporeal circulation (ECC).

Description

Inclusion Criteria:

Need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases

Exclusion Criteria:

  1. History of previously diagnosed hereditary coagulation and/or platelet disorders
  2. Refusal to receive blood transfusion
  3. Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization
  4. Diagnosis of hepatitis B, hepatitis C, and HIV
  5. Age > 85 years

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
(1) veno-venous ECMO
ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(2) veno-arterial ECLS
ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(3) LVAD (Heart Mate II)
LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(4) LVAD (Heart Ware)
LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(5) LVAD (Impella)
LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(6) Dialysis system
Patients being connected to a dialysis system
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(7) LVAD (Heart Mate III)
LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III)
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
(8) HLM
HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass
Device: ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of the platelet activation marker "beta-thromboglobulin"
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Helene Häberle, MD, University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany

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 30, 2015

Primary Completion (Actual)

June 10, 2020

Study Completion (Actual)

November 28, 2020

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSIMA

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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