CytoSorbents Corporation (CTSO)

[andy55q]

This new trial is being conducted at University Medical Centre, in Ljubljana, Slovenia which is internationally renowned for leading innovation in cardiovascular surgery. They are a site also for the first clinical implants of CARMAT bioprosthetic artificial heart - the worlds most advanced bioprosthetic artificial heart. Their transplant activity has been steadily growing year on year resulting in an extensive waiting list. They are the largest hospital centre in Slovenia with over 2000 beds and 7000 employees, and perform over 100,000 in-patient admissions per year, making it one of the largest hospitals centers in Central Europe.

Excerpt from the study purpose: "The balance of pro-inflammatory and anti-inflammatory mediators determines the inflammatory response and the clinical outcome. Accordingly, great efforts have been focused on therapeutic interventions aimed at reducing the inflammatory reactions during CPB, including pharmacologic strategies and modification of surgical techniques or mechanical devices. Such therapies may provide improvements in patient outcome after open heart operations. Among pharmacologic strategies is the prophylaxis with corticosteroids, which have been used during open heart surgery for more than 30 years. Many studies, both experimental and clinical, failed to produce evidence in favor of steroid treatment. As far as medical devices are concerned, the use of extracorporeal cytokine filter CytoSorb looks promising in cardiac surgery. It was recently approved by European Medicines Agency as an active treatment to fight cytokine storm."

Extracorporeal Cytokine Adsorption in Cardiac Surgery (IMEECCACS)
This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University Medical Centre Ljubljana
Sponsor:
University Medical Centre Ljubljana
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Gordana Taleska, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT02666703
First received: January 17, 2016
Last updated: January 24, 2016
Last verified: January 2016

https://clinicaltrials.gov/ct2/show?term=CytoSorb&rank=9