Coagulopathy and SIRS During ECC in Intensive Care

University Hospital Tuebingen

Status: Completed

Conditions: Disorder of Circulatory System

Treatments: Device: ECLS/ECC

Study type: Observational

Funder types: Other

Identifiers

NCT02352805

COSIMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 8 patient groups

(1) veno-venous ECMO

Description:

ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO)

Treatment:

Device: ECLS/ECC

(2) veno-arterial ECLS

Description:

ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS)

Treatment:

Device: ECLS/ECC

(3) LVAD (Heart Mate II)

Description:

LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II)

Treatment:

Device: ECLS/ECC

(4) LVAD (Heart Ware)

Description:

LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware)

Treatment:

Device: ECLS/ECC

(5) LVAD (Impella)

Description:

LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella)

Treatment:

Device: ECLS/ECC

(6) Dialysis system

Description:

Patients being connected to a dialysis system

Treatment:

Device: ECLS/ECC

(7) LVAD (Heart Mate III)

Description:

LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III)

Treatment:

Device: ECLS/ECC

(8) HLM

Description:

HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass

Treatment:

Device: ECLS/ECC