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Clinical trial comparing methods of controlling bleeding in cardiac patients

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Royal Columbian Hospital is one of 12 North American hospitals involved in a study that has been published in the Journal of the American Medical Association (JAMA).

Even though blood is red, the main ingredient–plasma–is a straw colour. Plasma is the liquid portion of blood and, for decades, has been the standard for treating excessive bleeding in trauma and surgical patients. According to Canadian Blood Services, some of this so-called “liquid gold” goes to hospitals for transfusions, but the majority is used to make life-saving medications, such as prothrombin complex concentrate (PCC), which is used to prevent bleeding and reverse the effects of blood thinners
(anticoagulants). 

Plasma arrives at hospitals in frozen form, and once thawed, has a limited shelf life. PCC comes in powder form and is stored at room temperature, making it a good option for remote communities or hospitals that don’t have ready access to donated blood products. Both compounds are effective at controlling bleeding and have saved countless lives. 

It’s estimated that 15 per cent of patients suffer excessive bleeding during cardiac surgery. The study Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial, set out to compare the efficacy of PCC to frozen plasma when treating cardiac patients. 

A total of 420 patients at 10 hospitals in Canada and two in the United States received either a PCC product with four blood clotting factors or frozen plasma. Royal Columbian Hospital recruited 63 patients for the study, making it the second highest recruiting site in North America.

The study found that PCC was better than frozen plasma at controlling bleeding in cardiac patients who required blood products. 

“The results show us that patients who receive PCC have less blood loss and massive bleeding, fewer adverse events, lower rates of transfusion and better clotting,” says Dr. Sukh Brar, one of the study’s principal investigators and an anesthesiologist at Royal Columbian Hospital. “This is a pivotal study because it gives us the clinical data to help optimize how we manage bleeding in patients who require a lot of blood products.” 

According to Dr. Brar, this study will change clinical practice
immediately. 

“In Fraser Health, many of our sites already use PCC and I expect the ratio of PCC to frozen plasma to increase, given the results of this study,” he says.

Dr. Brar is quick to credit the anesthesiology, cardiology, intensive care, perfusion, laboratory medicine, pharmacy, and nursing teams for their collaboration on the study. It is one of more than 90 active trials involving Fraser Health clinicians and staff in areas such as cardiology, gastroenterology, neurology, orthopedic surgery, and critical care. 

 “The FARES-II study is a great example of how Fraser Health clinicians and staff are working to integrate research with care,” says Kate Keetch, director, Evaluation and Research Services, Fraser Health. “Clinical trials provide our patients with advanced treatment options while at the same time supporting clinical sites to conduct research as important drivers of quality improvement and innovation in the system.” 

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