POISE-3 trial tranexamic arm results announced

06 April 2022

POISE-3: Tranexamic acid stems bleeding during non-cardiac surgery

Patients undergoing non-cardiac surgery would need fewer blood transfusions according to the results of a new international study that highlights the benefits of using tranexamic acid, a widely used drug, to reduce bleeding during operations and save lives.

Surgical bleeding accounts for 40 per cent of all blood transfusions, and more blood products are needed than are available worldwide.

The results of the Perioperative Ischemic Evaluation Study (POISE-3) study of nearly 10,000 patients investigated whether tranexamic acid (TXA) reduced life-threatening and major bleeding in patients undergoing non-cardiac surgery – without increasing major clotting complications.

The Australian and New Zealand POISE-3 trial was funded by the National Health and Medical Research Council (NHMRC) to run at 20 hospitals across the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN) under the leadership of anaesthetists Professor Kate Leslie AO, Dr Thomas Painter and Dr Elizabeth Maxwell.

TXA was given to patients at risk of bleeding or blood vessel complications. The study found that TXA did not increase blood clots, heart attack, stroke, or other major blood vessel complications in the 30 days after surgery.

In this trial, half of 9535 patients in 22 countries were randomly assigned TXA, half placebo. Patients were 45 years or older (average age 69 years); 44 per cent of them were female.

The study was published on April 2, 2022 in the New England Journal of Medicine, and simultaneously presented at American College of Cardiology’s (ACC) 2022 conference by senior author Professor P.J. Devereaux.

“Bleeding is a common problem in patients undergoing noncardiac surgery and it often results in patients requiring a blood transfusion. Our study demonstrates that tranexamic acid can prevent this problem,” said Professor Devereaux, a senior scientist at the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences (HHS).

“Additionally, our finding of a safe, effective reduction in surgical bleeding has the potential to help healthcare systems on a broader, trickle-down effect.”

“Surgical bleeding accounts for 40 per cent of all transfusions, and more blood products are needed than are available today around the world,” added Professor Devereaux, who is also a professor of medicine and of health research methods, evidence and impact at McMaster University, and a cardiologist and perioperative care physician at HHS.

“Reduced bleeding that’s safe for patients could address the challenge of insufficient blood supply and save more lives.”

“In our trial, tranexamic acid demonstrated a consistent reduction in the risk of bleeding based on several definitions, and it reduced the risk of receiving one or two to four transfusions,” says PHRI scientist and study co-author Associate Professor Maura Marcucci.

“Given that 300 million surgeries occur annually around the world, tranexamic acid has the potential for large public health and clinical benefits, added Associate Professor Marcucci, an assistant professor of medicine and of health research methods, evidence and impact at McMaster University, and an internal medicine physician at HHS.

POISE-3 was funded by the Canadian Institutes of Health Research (CIHR) Foundation Grant; NHRMC funding schemes (Australia); General Research Fund, Research Grant Council, Hong Kong, China; and the PHRI.

The publication of the results in the New England Journal of Medicine adds to the ever-growing track record of the ANZCA CTN as a leading clinical trials network in the world to deliver world-class multicentre trials in pain, anaesthesia and perioperative medicine.

Dr Painter who along with invaluable support from the ANZCA CTN office and the Anaesthesia Research Coordinators Network (ARCN) was National Leader for the trial said: “I want to make a special mention of the amazing contribution from all of the Australian and New Zealand sites who continued to recruit through extraordinary circumstances and contributed an incredible 743 patients which is no mean feat.

“I would like to especially mention my New Zealand colleagues Dr Elizabeth Maxwell and Ms Davina McAllister as well as my Australian support team of Professor Kate Leslie AO, Ms Gillian Ormond, Ms Allison Kearney and Ms Karen Goulding.”

Dr Painter will present the results at the late breaking trials session at the 2022 ANZCA annual scientific meeting on Tuesday 3 May.

Last updated 11:02 6.04.2022