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Coagulopathy and SIRS During ECC in Intensive Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352805
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
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.

Condition or disease Intervention/treatment
Disorder of Circulatory System Device: ECLS/ECC

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.

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients
Actual Study Start Date : January 30, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Plasma concentration of the platelet activation marker "beta-thromboglobulin" [ Time Frame: 48 hours ]

Biospecimen Retention:   Samples With DNA
human whole blood and blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352805


Locations
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Germany
Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Helene Häberle, MD University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02352805    
Other Study ID Numbers: COSIMA
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Keywords provided by University Hospital Tuebingen:
Extracorporeal circulation, ventricular assist device
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders