The U.K. TISORB study is a 30-patient, open-label, prospective, multi-center, single arm clinical trial designed to evaluate the ability of CytoSorb®, when used in patients undergoing emergency open heart surgery within 48 hours of their last dose of ticagrelor, to remove ticagrelor and reverse the inhibitory effect of the drug on platelet aggregation. The trial is expected to complete by August 2020. Platelets are small cell fragments that are necessary to form blood clots, and without functioning platelets that can aggregate or stick together, surgical patients are at high risk of bleeding during and after surgery. Ticagrelor (Brilinta®, Astra Zeneca) is a widely-used anti-platelet agent used to decrease cardiovascular risk and risk of stroke in patients with a known history of heart disease or heart attack. However, when patients on ticagrelor suffer from a cardiac event that requires emergency cardiac surgery, approximately 25-30% will have severe or massive peri-operative bleeding complications that contributes to a high risk of death and major costs to the healthcare system. CytoSorb has already demonstrated the ability to remove ticagrelor rapidly and efficiently from human blood in vitro. Meanwhile, a retrospective case series reported by clinicians at Asklepios Klinik St. Georg in Hamburg, Germany on the investigational use of CytoSorb to reverse the effects of ticagrelor during emergency cardiac surgery demonstrated a greatly reduced risk of bleeding complications and the need for repeat surgery to explore the source of bleeding, with extrapolations showing projected cost savings of £3,982, or approximately $5,000 USD, per patient in a U.K. based study.
Dr. Nawwar Al-Attar, Consultant Cardiac & Transplant Surgeon at the Golden Jubilee National Hospital in Glasgow, Scotland, an investigator in the TISORB study, commented, "We are excited to participate in this prospective study to further evaluate the effectiveness of the CytoSorb adsorber to remove ticagrelor and restore platelet function in patients on the drug who require emergency cardiac surgery. This is a large unmet need for these patients who have an increased risk of suffering from catastrophic bleeding and its resultant complications. Treatment with CytoSorb has the potential to significantly improve the outcomes for these patients as well as to reduce the costs associated with these bleeding complications."
Dr. Kenichi Tanaka, Professor and Head of Cardiothoracic Anesthesiology at the University of Maryland School of Medicine added, "Anti-thrombotic drugs such as ticagrelor are important for patients to prevent heart attacks and strokes. However, for patients who require emergency cardiothoracic surgery, being on these drugs greatly increases the risk of serious bleeding. Some life-saving surgeries need to be done immediately instead of waiting for a few days until the drug wears off. Having the ability to remove anti-thrombotic drugs prior to, or during emergency cardiothoracic surgery, has the potential to allow these procedures to be performed safely in critically-ill patients by reducing bleeding and possible complications related to allogeneic blood transfusions. The initiation of the TISORB study is an important first step toward filling an unmet need in perioperative management of ticagrelor."
Dr. Eric Mortensen, MD, PhD, Chief Medical Officer of CytoSorbents, commented, "The initiation of the TISORB study is an important milestone for our company. This study, and a planned companion study, are expected to provide confirmatory mechanistic, clinical, and cost-effectiveness data, that if successful, may support broader use of CytoSorb in the United Kingdom and elsewhere. This is the first time that CytoSorbents has sponsored a clinical trial in the U.K. and we look forward to collaborating with our investigator colleagues.
