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Toronto (Feb. 1, 2017) - The Peter Munk Cardiac Centre at Toronto General Hospital today announced the launch of the FIBrinogen REplenishment in Surgery (FIBRES) study in acquired fibrinogen deficiency. Fibrinogen is a protein that helps form blood clots. FIBRES is a prospective, multi-centre, randomized, active-control, phase 3 clinical trial comparing fibrinogen concentrate with cryoprecipitate (a plasma-based frozen blood product) for the treatment of acquired hypofibrinogenemia in bleeding adult cardiac surgical patients.
"Bleeding is a common and serious complication of cardiac surgery; however, there remain many areas of uncertainty about the best transfusion management strategies," says Dr. Barry Rubin, Medical Director, Peter Munk Cardiac Centre, University Health Network (UHN). "Through their findings, our accomplished clinical research team will continue to lead the way for improving the management of bleeding in cardiac surgery and other settings, with the goal of improving outcomes and reducing costs," he says.
The primary objective of this study is to demonstrate that the fibrinogen concentrate, Octafibrin, is non-inferior to cryoprecipitate with respect to efficacy in bleeding cardiac surgical patients in whom fibrinogen supplementation is ordered according to accepted clinical standards. Efficacy will be measured by the total number of allogeneic blood products (ABPs) administered during the first 24 hours after termination of cardiopulmonary bypass (CPB). Up to 12 Canadian hospitals and approximately 1,200 adult cardiac surgical patients who require fibrinogen supplementation as a result of excessive bleeding due to acquired hypofibrinogenemia will participate in the study.
"Emerging evidence supports early goal-directed therapy guided by point of care algorithms in bleeding management," says Dr. Keyvan Karkouti, principle investigator, Deputy Anesthesiologist-in-Chief, Toronto General Hospital, and Scientist at the Peter Munk Cardiac Centre and Toronto General Hospital Research Institute. "With the generous support of Octapharma, this study aims to explore the specific question of whether bleeding patients would be best treated with cryoprecipitate or fibrinogen concentrate. The practical and theoretical advantages of purified fibrinogen concentrate over cryoprecipitate include improved safety, ease of administration, predictable and robust effect on fibrinogen plasma levels." he says. The results of this trial will improve the care of the bleeding cardiac surgery patient and pave the way for future trials in this under-studied, high-risk population.
Octafibrin, the human fibrinogen concentrate that will be used in this study, is under development for the treatment of congenital fibrinogen deficiencies by Octapharma AG, one of the largest research based human protein products companies in the world. "The safe and optimal use of human proteins has been an enduring goal since our inception and we are pleased that this major grant seeks to address an important clinical question for a complication that is prognostically important and has not been adequately studied to date. In partnership with researchers at the Peter Munk Cardiac Centre, we hope to demonstrate that the use of a purified fibrinogen concentrate, in place of cryoprecipitate, will further support the appropriate use of fluids in Canada," says Sri Adapa, General Manager of Octapharma Canada.
Fibrinogen is a critical protein involved in clotting and is thought to be one of the key factors contributing to serious bleeding after cardiac surgery and after traumatic injury. "The current standard of care across Canada and the United States is to administer cryoprecipitate. There are drawbacks to this strategy – the product takes 45 minutes to prepare, it has variable fibrinogen content, is not a pure product, and is not virally inactivated. Fibrinogen concentrates on the other hand take about 15 minutes to prepare, have uniform fibrinogen content, is purified and virally inactivated. It appears to be a superior product but we need to validate that this is true in a clinical trial and that fibrinogen concentrates are not associated with unintended adverse events," says Dr. Jeannie Callum, Director of Transfusion Medicine at Sunnybrook Health Sciences Centre and co-investigator on the FIBRES Study.
The Peter Munk Cardiac Centre is the premier cardiac centre in Canada. Since it opened in 1997, the Centre has saved and improved the lives of cardiac and vascular patients from around the world. Each year, approximately 55,000 patients receive innovative and compassionate care from multidisciplinary teams in the Peter Munk Cardiac Centre, and the Centre trains more cardiologists, cardiovascular surgeons and vascular surgeons than any other hospital in Canada. The Centre is based at the Toronto General Hospital and the Toronto Western Hospital - members of University Health Network. www.petermunkcardiaccentre.ca
Phone: 416 340 4636