Findings from a new clinical trial found that OTC aspirin can be just as effective as an injectable blood thinner, low-molecular-weight heparin to prevent life-threatening blood clots for patients hospitalized with fractures.
The findings, published in NEJM, could even lead surgeons to change their practice and administer aspirin to these patients.
“Many patients with fractures will likely strongly prefer to take a daily aspirin over receiving injections after we found that both give them similar outcomes for prevention of the most serious outcomes from blood clots,” said the study’s lead investigator Robert V. O’Toole, MD, chief of orthopaedics at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center (UMMC), in a news release. “We expect our findings from this large-scale trial to have an important impact on clinical practice that may even alter the standard of care.”
The study enrolled 12,211 patients with leg or arm fractures at 21 trauma centers in the United States and Canada. The patients’ conditions necessitated surgery or pelvic fractures regardless of the treatment. Half were randomly assigned to receive 30 mg of injectable low molecular-weight heparin twice daily. The other half received 81 mg of aspirin twice daily. Patients were followed for 90 days to measure health outcomes from the two treatments.
The main finding of the study was that aspirin was “non-inferior,” or no worse than low molecular-weight heparin in preventing death from any cause—47 patients in the aspirin group died, compared with 45 patients in the heparin group. The researchers also found no differences between the two groups in pulmonary embolisms. The incidence of bleeding complications, infection, wound problems, and other adverse events from the treatments was also similar in both groups.
Of all the outcomes studied, the only potential difference noted was in deep vein thrombosis. This condition was relatively uncommon in both groups as it occurred in 2.51% of patients in the aspirin group, and in 1.71% of patients in the heparin group.
“This relatively small difference was driven by clots lower in the leg, which are thought to be of less clinical significance and often do not require treatment,” said study author Deborah Stein, MD, MPH, director of Adult Critical Care Services at UMMC, in the news release.
An estimated 1 million American are hospitalized each year with extremity fractures. According to Mark Gladwin, MD, from the University of Maryland School of Medicine, findings from this new study could help prevent potentially fatal blood clots in these patients using a medication that is cheaper and much easier to administer.
"Given these important results, we can expect the guidelines for the prevention of blood clots to be revised to include the option of aspirin for patients with traumatic bone fractures,” he said in the news release.