A landmark clinical trial published in\u00a0the\u00a0prestigious New England Journal of Medicine found\u00a0that tranexamic acid\u00a0reduced transfusions\u00a0across major surgeries\u00a0without increasing\u00a0the\u00a0risk of\u00a0dangerous\u00a0blood clots.\u00a0The trial was sponsored and coordinated by the University of Manitoba (UM) and co-led by researchers at UM and The Ottawa Hospital.<\/p>\n
Tranexamic acid is an inexpensive\u00a0drug that prevents excessive bleeding and stabilizes blood clots. It has been used in cardiac and some orthopedic surgeries for\u00a0over 30 years, but doctors have been uncertain if it can safely be used in other major surgeries, especially cancer surgeries.<\/p>\n
This pan-Canadian clinical trial studied over 8,000 major surgeries to determine if tranexamic acid reduced bleeding and blood transfusion without increasing the risk of clots. The results of the trial support expanding its use to all major surgeries where patients face a high risk of blood loss.<\/p>\n
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This is transformative to patient care and globally has the potential to save millions of units of red blood cells each year.”\u00a0<\/p>\n
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Dr.\u00a0Brett Houston, co-first author and hematologist and clinician-scientist, University of Manitoba and\u00a0CancerCare\u00a0Manitoba<\/p>\n
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Major surgery includes procedures of the head, chest, abdomen, or pelvis, and typically requires general anesthetic and a hospital stay. For these surgeries, more than one in 20 patients will\u00a0need\u00a0a blood transfusion.\u00a0<\/p>\n
“If\u00a0tranexamic acid\u00a0is universally adopted across major surgeries, it\u00a0will improve surgical safety for millions of patients around the world. In Canada alone, adopting this drug across the board could reduce the number of patients who need a transfusion by 25 per cent annually and reduce the number of blood units required by 10 per cent,” said Dr.\u202fDaniel McIsaac, co-first author and anesthesiologist and senior scientist at The Ottawa Hospital and Clinical Research Chair in Perioperative Innovation at the University of Ottawa.\u00a0<\/p>\n
Universal adoption of the drug also has the potential to save significant money.<\/p>\n
“One transfusion in Canada costs more than $700 CAD, compared to under $10 for tranexamic acid. We estimate that the routine adoption of tranexamic in major non-cardiac surgeries could save 50,000 units of blood each year in Canada and millions of units around the world; the savings to health-care systems will be profound,” said the trial chair and co-senior author Dr.\u00a0Ryan Zarychanski, a hematologist, critical care physician, and clinician-scientist at the University of Manitoba and\u00a0CancerCare\u00a0Manitoba.\u00a0<\/p>\n
To discover if tranexamic acid reduces blood transfusion without increasing the risk of blood clots,\u00a0the team\u00a0used a\u00a0cluster-crossover trial design to\u00a0randomly assign hospitals to\u00a0treat\u00a0patients having major surgery\u00a0with\u00a0high risk of blood loss to tranexamic acid\u00a0or placebo. The hospitals would then switch treatment every four weeks for approximately two years. The Ottawa Hospital’s\u00a0Ottawa Methods Centre\u00a0played a key role in designing this\u00a0trial\u00a0to\u00a0answer\u00a0the research question\u00a0quickly\u00a0and efficiently.\u00a0<\/p>\n
The\u00a0study team\u00a0accessed hospital\u00a0information on\u00a0transfusions\u00a0and clots\u00a0directly from clinical and administrative health data sources housed in Manitoba and at\u00a0ICES. They analyzed data from\u00a08,273\u00a0major\u00a0surgeries\u00a0performed\u00a0at 10 Canadian hospitals\u00a0between February 2022\u00a0and\u00a0March 2024.<\/p>\n
The researchers\u00a0found\u00a0that 7.4\u00a0per cent\u00a0of the patients who received tranexamic acid\u00a0needed transfusions compared to\u00a09.8\u00a0per cent\u00a0in\u00a0the\u00a0placebo group.\u00a0For every 100 patients treated with tranexamic acid, 10 units of blood could be saved. Importantly, they found that tranexamic acid did not increase the risk of\u00a0venous blood clots\u00a090 days\u00a0after surgery. The rate\u00a0of blood clotting\u00a0in\u00a0both\u00a0the treatment and placebo\u00a0groups was\u00a0the same, at\u00a02.1\u00a0per cent.\u00a0<\/p>\n
One unique aspect of the study was that 60 percent, or about 5,000 participants, had surgery to remove cancer. People with cancer are\u00a0often left out of\u00a0these kinds of studies, even though they are a large part of the surgical population. The trial found that tranexamic acid during major surgery was safe and effective even for cancer patients, who are at a higher risk of blood clots due to cancer.\u00a0<\/p>\n
“We hope\u00a0our findings will\u00a0reassure care providers that this drug is safe and effective at reducing bleeding\u00a0and remove a barrier to\u00a0its use\u00a0in most major surgeries,”\u00a0said\u00a0Dr.\u00a0Dean Fergusson, co-senior author and Deputy Scientific Director, Clinical Research and senior scientist at The Ottawa Hospital and professor at the University of Ottawa.\u00a0<\/p>\n
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