Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) veno-venous ECMO | ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO) |
| |
| (2) veno-arterial ECLS | ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS) |
| |
| (3) LVAD (Heart Mate II) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II) |
| |
| (4) LVAD (Heart Ware) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware) |
| |
| (5) LVAD (Impella) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella) |
| |
| (6) Dialysis system | Patients being connected to a dialysis system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECLS/ECC | Device | Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of the platelet activation marker "beta-thromboglobulin" | 48 hours |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helene Häberle, MD | University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen | Tübingen | 72076 | Germany |
Not provided
Not provided
Not provided
Not provided
human whole blood and blood plasma
| (7) LVAD (Heart Mate III) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III) |
|
| (8) HLM | HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass |
|