Coagulopathy and SIRS During ECC in Intensive Care

NCT02352805 | Completed

• 1 other identifier: COSIMA
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Circulatory System

Keywords

Extracorporeal circulation, ventricular assist device

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of the platelet activation marker "beta-thromboglobulin"

  48 hours

Study Arms (8)

(1) veno-venous ECMO

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

Device: ECLS/ECC

(2) veno-arterial ECLS

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

Device: ECLS/ECC

(3) LVAD (Heart Mate II)

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

Device: ECLS/ECC

(4) LVAD (Heart Ware)

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

Device: ECLS/ECC

(5) LVAD (Impella)

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

Device: ECLS/ECC

(6) Dialysis system

Patients being connected to a dialysis system

Device: ECLS/ECC

(7) LVAD (Heart Mate III)

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

Device: ECLS/ECC

(8) HLM

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

Device: ECLS/ECC

Interventions

ECLS/ECC DEVICE

Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery

(1) veno-venous ECMO; (2) veno-arterial ECLS; (3) LVAD (Heart Mate II); (4) LVAD (Heart Ware); (5) LVAD (Impella); (6) Dialysis system; (7) LVAD (Heart Mate III); (8) HLM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

human whole blood and blood plasma

Study Officials

• Helene Häberle, MD

  University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: January 30, 2015
• Primary Completion: June 10, 2020
• Study Completion: November 28, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

DE (1)