Multicenter trial of over 12,000 orthopedic trauma patients potentially changing standards of care – ScienceDaily

Patients with fractures in the hospital usually receive an injectable blood-thinning drug, low molecular weight heparin, to prevent life-threatening blood clots. However, a new clinical trial found that inexpensive, over-the-counter aspirin is just as effective. Results published today in New England Journal of Medicinemay lead surgeons to change their practices and give aspirin to these patients.

The multicenter, randomized clinical trial, which included more than 12,000 patients at 21 trauma centers in the United States and Canada, is the largest trial ever conducted in orthopedic trauma patients. This multidisciplinary collaboration between orthopedic and trauma surgeons points to the importance of evaluating techniques used to prevent postoperative complications, such as blood clots and infections, through high-quality, face-to-face comparative studies.

The trial was co-led by the Department of Orthopedics at the University of Maryland School of Medicine (UMSOM) and the Major Trauma Research Consortium (METRC) based at the Johns Hopkins Bloomberg School of Public Health.

The study’s principal investigator, Robert F. MD, Hansjörg Wyss Medical Foundation Endowed Professor of Orthopedic Traumatology at UMSOM and Chief of Orthopedics in the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center (UMMC). “We expect that our findings from this large-scale trial will have an important impact on clinical practice that may change the standard of care.”

Blood clots cause as many as 100,000 deaths in the United States each year, according to the US Centers for Disease Control (CDC). Patients with fractures that require surgery are more likely to develop blood clots in the lungs and extremities. Large clots in the lungs can be life threatening. Current guidelines recommend prescribing low molecular weight heparin (enoxaparin) for the prevention of these clots, although smaller clinical trials in total joint replacement surgery suggest a potential benefit of aspirin as a less expensive and more widely available option.

The study included 12,211 patients with leg or arm fractures that required surgery, or pelvic fractures, regardless of treatment. Half of them were randomly assigned to receive 30 mg. Low molecular weight heparin by injection twice daily. The other half received 81 mg. Aspirin twice daily. Patients were followed for 90 days to measure health outcomes from the two treatments.

The study’s main finding was that aspirin was “not inferior,” or no worse than low-molecular-weight heparin at preventing death from any cause — 47 patients died in the aspirin group, compared with 45 patients in the heparin group. For another important complication, the researchers also found no differences between the two groups in clots in the lungs (pulmonary embolism). 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 possible difference was in blood clots in the legs, called deep vein thrombosis. This condition was relatively uncommon in both groups, occurring in 2.5 percent of patients in the aspirin group, and in 1.7 percent of patients in the heparin group.

“This relatively small difference was driven by lower leg clots, which are thought to be of less clinical importance and often do not require treatment,” said study co-principal investigator Deborah Stein, MD, MPH, professor of surgery at UMSOM and director of adult intensive care services at the University of Michigan. Muhammadiyah MMC.

The $11.7 million study was funded by the Patient-Centered Outcomes Research Institute (PCORI), (PCS-1511-32745), an independent, nonprofit organization that funds comparative clinical effectiveness research to help patients and clinicians make informed healthcare decisions. .

said principal investigator of the Center for Study Methods Renan Castillo, PhD, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health.

The trial was called thrombotic prophylaxis in orthopedic injuries, or thrombosis prevention. Patients enrolled in the trial were treated at the R Adams Cowley Shock Trauma Center at UMMC and 20 other trauma centers in 15 other states, plus two in Canada. Recruitment began in April 2017 and will continue through 2021.

“Many patients don’t like giving themselves injections. It’s not fun in terms of giving the actual injection because it burns, and your stomach tends to bruise more easily compared to aspirin,” said Debra Marvell, 53, of Columbia. , MD, who acted as a counselor to the patients in the study. She received Lovenox (low molecular weight heparin) after shattering her legs in a pedestrian accident in 2015, which required multiple surgeries at the University of Maryland Trauma Center. “Patients also prefer aspirin because Lovenox can be expensive on an insurance basis.”

Mark T. said: Chair of Medical Affairs, University of Maryland, Baltimore, John Z. and Ikeku Powers Distinguished Professor and Dean of the University of Maryland School of Medicine. “Given these important findings, we can expect that anticoagulant prevention guidelines will be revised to include the option of aspirin for patients with traumatic bone fractures.”

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