8:00AM CytoSorbents Announces FDA Approved US Air Force Funded Human Trauma Pilot Study for Rhabdomyolysis (CTSO) 0.12 : Co announced that the United States Food and Drug Administration (FDA) has granted approval to begin a U.S.-based human pilot study using CytoSorb? for the treatment of rhabdomyolysis as a result of trauma under an Investigational Device Exemption (IDE). Rhabdomyolysis is caused by the massive release of myoglobin from severely injured skeletal muscle that can lead to kidney failure. The study was initiated by and will be funded by the U.S. Air Force. CytoSorbents is the official sponsor of the study, and expects the study to begin this year.
Here is more CTSO info:
Cytokine Removal in Cardiopulmonary Bypass Patients (CytoSorb)
This study is not yet open for participant recruitment.
Verified June 2013 by Medical University of Vienna
Medical University of Vienna
CytoSorbents Europe GmbH
Information provided by (Responsible Party):
Dr. Martin Bernardi, Medical University of Vienna
First received: June 7, 2013
Last updated: June 13, 2013
Last verified: June 2013
History of Changes