Coagulopathy and SIRS During ECC in Intensive Care

Completed

• Conditions: Disorder of Circulatory System
• Interventions: Device: ECLS/ECC

• Registration Number: NCT02352805
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-28
• Study Start: 2015-01-30
• Study First Posted: 2015-02-02
• Primary Completion: 2020-06-10
• Study Completion: 2020-11-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
(7) LVAD (Heart Mate III)	ECLS/ECC	LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III)
(8) HLM	ECLS/ECC	HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass
(3) LVAD (Heart Mate II)	ECLS/ECC	LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II)
(4) LVAD (Heart Ware)	ECLS/ECC	LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware)
(1) veno-venous ECMO	ECLS/ECC	ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO)
(6) Dialysis system	ECLS/ECC	Patients being connected to a dialysis system
(2) veno-arterial ECLS	ECLS/ECC	ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS)
(5) LVAD (Impella)	ECLS/ECC	LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella)

Primary Outcome Measures

Name	Time	Method
Plasma concentration of the platelet activation marker "beta-thromboglobulin"	48 hours

Trial Locations

Locations (1)

Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen; 🇩🇪 Tübingen, Germany