Tranexamic acid versus placebo to reduce perioperative blood transfusion in patients undergoing major liver resection: a pilot randomized controlled trial

Surgery (liver resection) is the optimal treatment for patients with cancer that originates in, or has spread to the liver. Despite improvements and advances in liver resection surgery, many patients require blood transfusion during or after their operation due to blood loss from surgery. While blood transfusions are generally safe, they do carry serious risks. In particular, patients who receive blood transfusions are more likely to suffer from complications following surgery including death. Furthermore, patients who receive blood transfusion have a higher likelihood of cancer recurrence. The likelihood of requiring a blood transfusion during or following liver resection is approximately 30-40%. We are studying the effect of a drug named 'tranexamic acid' (TXA) on blood loss and the need for blood transfusion after liver resection. Many studies have examined TXA in patients having other types of surgery and it appears to be safe and effective at reducing blood loss and the need for blood transfusions. However, the effect of TXA has not been well-studied in patients having major liver surgery and it is rarely used in these patients in Canada. This funding will support a pilot trial to establish the feasibility of proceeding with a larger trial in Canada. Participating study sites for this trial represent four distinct geographic areas in Canada (Ontario, Western Canada, Atlantic Canada, and Quebec). Based on the results of this pilot trial we will expand to include other sites within Canada. In the trial, patients will be randomly assigned to receive either TXA or placebo (saline). We will measure the extent of blood loss and blood transfusions in these patients. We anticipate that TXA will reduce the likelihood of blood transfusion by approximately one third. Over 2000 patients undergo liver resection each year in Canada and could potentially benefit from this simple, cheap intervention.

KARANICOLAS, Paul

Sunnybrook Research Institute

Canadian Blood Services-CIHR Partnership Operating Grant Program

Ontario

$248,319