Coagulopathy and SIRS During ECC in Intensive Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Disorder of Circulatory System

Intervention / Treatment
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* Device: ECLS/ECC


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal circulation, ventricular assist device