Coagulopathy and SIRS During ECC in Intensive Care

Disorder of Circulatory System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352805
• Other study ID #: COSIMA
• Status: Completed
• Start date: January 30, 2015
• Est. completion date: November 28, 2020

Study information

• Verified date: April 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 28, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Disorder of Circulatory System
• Hemostatic Disorders

Intervention

Device:
• ECLS/ECC
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery

Locations

Country	Name	City	State
Germany	Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of the platelet activation marker "beta-thromboglobulin"		48 hours