Patients who’ve surgery to repair bone fractures typically receive a variety of injectable blood thinner, low-molecular-weight heparin, to stop life-threatening blood clots, but a latest clinical trial found that over-the-counter aspirin is just as effective. The findings, presented today on the Orthopaedic Trauma Association (OTA) annual meeting in Tampa, FL, could cause surgeons to alter their practice and administer aspirin as an alternative to those patients.
The multi-center randomized clinical trial of greater than 12,000 patients at 21 trauma centers within the U.S. and Canada, is the largest-ever trial in orthopedic trauma patients. The trial was co-led by the Department of Orthopaedics on the University of Maryland School of Medicine (UMSOM) and the Major Extremity Trauma Research Consortium (METRC) based on the Johns Hopkins Bloomberg School of Public Health.
We expect our findings from this large-scale trial to have a crucial impact on clinical practice, and potentially even change the usual of care. Orthopaedic trauma patients are commonly prescribed the blood thinner low-molecular-weight heparin to stop blood clots for weeks following surgery. Not only does the medication should be injected, it might probably even be quite expensive in comparison with aspirin.”
Robert V. O’Toole, MD, Study’s Principal Investigator, the Hansjörg Wyss Medical Foundation Endowed Professor in Orthopaedic Trauma at UMSOM and Head of the Division of Orthopaedic Traumatology
Blood clots cause as many as 100,000 deaths within the U.S. annually, in accordance with the U.S. Centers for Disease Control (CDC). Patients who experience fractures that require surgery – an estimated 1 million people within the U.S. annually – are at increased risk of developing blood clots within the veins, including a fatal pulmonary embolism, which is a clot within the lung. Current guidelines recommend prescribing low-molecular-weight heparin (enoxaparin), although research in total joint alternative surgery suggested a possible good thing about aspirin as a less-expensive, widely available option.
Dr. O’Toole, who can also be Chief of Orthopaedics on the R Adams Cowley Shock Trauma Center on the University of Maryland Medical Center (UMMC), presented the outcomes of the landmark clinical trial on the OTA annual meeting. The $12 million study was funded by the Patient-Centered Outcomes Research Institute (PCORI), (PCS-1511-32745), an independent, nonprofit organization that funds research to assist patients and clinicians make better-informed healthcare decisions.
The study enrolled 12,211 patients with leg or arm fractures that necessitated surgery or pelvic fractures no matter the precise treatment. Half were randomly assigned to receive 30 mg of injectable low-molecular-weight heparin twice each day. The opposite half received 81 mg of aspirin twice each day. The follow-up period after surgery was 90 days.
The primary finding of the study was that aspirin was “noninferior,” or no worse, than low-molecular-weight heparin in stopping death from any cause – 47 patients within the aspirin group died compared with 45 patients within the heparin group. Secondary outcomes noted no differences in non-fatal pulmonary embolism. The incidence of bleeding complications and all other safety outcomes was similar in each groups. Of all of the outcomes studied, the one potential difference noted was fewer blood clots within the legs within the low-molecular-weight heparin group. This relatively small difference was driven by clots lower within the leg, that are of unclear clinical importance.
“With data from greater than 12,000 patients, this study provides clear evidence that aspirin is a viable option for stopping blood clots within the lung and death in patients who require surgery for orthopaedic trauma,” said Andrew Pollak, MD, the James Lawrence Kernan Professor and Chair of the Department of Orthopedics at UMSOM and Senior Vice President and Chief Clinical Officer for the 11-hospital University of Maryland Medical System (UMMS).
The trial was called PREVENTion of CLots in Orthopaedic Trauma, or PREVENT CLOT. Patients enrolled within the trial were treated on the R Adams Cowley Shock Trauma Center at UMMC and 20 other trauma centers in 15 other states and two in Canada. Recruitment began in April 2017 and continued through 2021. Deborah Stein, MD, MPH, Professor of Surgery at UMSOM and Director of Adult Critical Care Services at UMMC, and Renan Castillo, PhD, an Associate Professor of Health Policy and Management on the Johns Hopkins Bloomberg School of Public Health, are co-principal investigators.
“This exciting trial, the biggest ever conducted in orthopedic trauma patients, provides vital guidance to surgeons in helping to stop potentially fatal blood clots after fracture surgery through the use of a drugs that’s each inexpensive and straightforward to manage,” said Mark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine.
Source:
University of Maryland School of Medicine