We can’t predict when there will be another “tainted blood” outbreak, but we do know that we are now safer than ever before, according to a landmark study conducted at Toronto General Hospital.
For decades, North American hospitals have been using cryoprecipitate to replace fibrinogen, an important clotting factor, in patients who bleed during or after surgery. Cryoprecipitate is a blood product derived from plasma that is both costly and cumbersome to produce, and slow and inefficient in an operating room when time is of the essence. Fibrinogen concentrate, a better and safer blood product, is commonly used in Europe but not widely so in North America.
“We had a purified and likely safer product,” says Dr. Keyvan Karkouti, Chief of Anesthesia at Toronto General Hospital (TG). “But, because we didn’t have comparative data, we didn’t make the switch.”
Dr. Karkouti and Dr. Jeannie Callum, co-Principle Investigators, and a team of scientists, set out to prove fibrinogen was in fact the safer and better blood product and the results of the multicentre, randomized clinical trial conducted at 11 hospitals across Canada was published Oct. 21 in The Journal of the American Medical Association (JAMA).
This study proves that fibrinogen concentrate is just as effective as cryoprecipitate with more benefits to both the bottom line and to patient welfare. Cryoprecipitate comes from blood collected by donors, which is then processed, frozen and shipped to urban centres. It is an expensive and time-consuming production process for our blood suppliers that also negatively impacts their ability to produce other urgently needed blood components such as platelets.
In terms of safety, the fibrinogen concentrate is solvent-detergent treated and multi-filtered to inactivate any potential pathogens. And because it does not require freezing, it can be used almost instantly. With cryoprecipitate, it takes up to 45 minutes to thaw and combine the 10 units that may or may not have the right balance of fibrinogen needed to stop the bleeding. It is very common in trauma, obstetrical and cardiac surgery cases to have a patient who requires blood to survive, and in those cases, every minute counts.
“We are the doctors that send our patients into surgery,” says Dr. Michael Farkouh, lead cardiologist on the trial and Peter Munk Chair in Multinational Clinical Trials at TG. “We want them to have optimal outcomes and this clinical trial will lead to safe and effective management of bleeding in surgery.”
Currently in Canada, fibrinogen concentrate is approved for use only for patients who have low fibrinogen levels from birth, which is a very rare condition. Its use in the much more common situation of surgical bleeding because of low fibrinogen levels is considered off label. Because of this landmark study, such patients will also be able to receive the best available treatment.
“The study provides high quality evidence demonstrating the comparative efficacy of fibrinogen concentrate and cryoprecipitate,” says Dr. Oksana Prokopchuk-Gauk, Chair, National Advisory Committee on Blood and Blood Products (NAC). “These results will help inform future NAC statements on appropriate fibrinogen replacement.”
The Canadian Blood Services currently has two fibrinogen concentrate products available – Fibryga (Octapharma) and RiaSTAP (CSL Behring). The use of these products in acquired hypofibrinogenemia is currently off label.
Cover photo by Hush Naidoo