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Completed

NCT Number: NCT02352805

Coagulopathy and SIRS During ECC in Intensive Care

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ECLS/ECC

Device

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

Primary outcomes

  1. Plasma concentration of the platelet activation marker "beta-thromboglobulin"

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2015
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.