Clinical trial NCT02352805: Coagulopathy and SIRS During ECC in Intensive Care
Official title: A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Circulatory System
Keywords: Extracorporeal circulation, ventricular assist device
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of the platelet activation marker "beta-thromboglobulin"
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen
Study officials:
affiliation: University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany
name: Helene Häberle, MD
role: PRINCIPAL_INVESTIGATOR
References: