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A randomized pragmatic trial comparing the complications and safety of blood clot prevention medicines used in orthopedic trauma patients
Investigator (PI): O'Toole, Robert
Performing Organization (PO): (Current): University of Maryland, School of Medicine, Department of Orthopaedics / (410) 328-6040
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/PCS-1511-32745
Funding: Total Award Amount: $11,199,616
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: There are 6 million fractures treated each year in the United States, and 2.3 million patients are admitted each year after trauma. Injuries that break certain bones, like the hip or thigh bone, are very common and associated with a particularly high risk of blood clots. If a patient does develop a blood clot, it can require the patient to take months of additional medications or can possibly even become fatal. However, medications to prevent blood clots can increase the risk of bleeding or other complications. Despite the frequency of these injuries and the potential devastating impact that blood clots can have on patients' lives, we currently do not know the best clot prevention medication for trauma patients. Current guidelines indicate that patients with certain fractures should be given medication to help prevent blood clots. Low molecular weight heparins (LMWHs) are medicines that have been used to prevent blood clots in the legs (deep vein thrombosis) of trauma patients since the 1990s. Today, despite a lack of good evidence, LMWHs remain in widespread use for patients with fractures. Aspirin is another commonly used clot prevention medicine that may have a similar or even superior ability to prevent blood clots in the legs and potentially fatal clots in the lungs (pulmonary embolism) that can occur after a traumatic injury. However, there have not been any studies to date that compare LMWHs with aspirin in preventing blood clots in fracture patients. This study should answer a question that is important to the millions of people who suffer a traumatic injury every year in the United States and are therefore at high risk for a blood clot. The study will compare the rates of death, blood clots in the lung, complications after surgery, patient satisfaction, out-of-pocket costs, and minor blood clots in patients to determine which medication is more effective in blood clot prevention after fractures. Patients and stakeholders have already taken an active role in developing this research proposal. Our research team comprises trauma survivors, blood clot survivors, caregivers, frontline clinicians, professional organizations, medical insurers, and experts in this field of research. In preparation for this study, we surveyed 232 trauma patients to determine the outcomes related to blood clots that they believed were most important. Our study is designed to respond to the concerns expressed by those patients. Trauma patients have historically been under-represented in research. The time-sensitive nature of traumatic injuries and the complicated medical condition of trauma patients at the time of hospital admission has long been a deterrent to scientific investigation. Our patients and caregiver team members have been crucial to designing this study so that it answers an important research question for patients and physicians while being respectful to the challenging circumstances faced by patients and their caregivers.
MeSH Terms:
  • Aspirin /therapeutic use
  • * Blood Coagulation
  • Caregivers
  • Fractures, Bone /complications
  • /surgery
  • Health Care Costs
  • Heparin, Low-Molecular-Weight /therapeutic use
  • Humans
  • Orthopedics /*methods
  • Patient Admission
  • Patient Safety
  • Patient Satisfaction
  • Preventive Medicine /methods
  • Pulmonary Embolism /prevention & control
  • Randomized Controlled Trials as Topic
  • Research Design
  • United States
  • Venous Thrombosis /*prevention & control
  • Wounds and Injuries /therapy
Country: United States
State: Maryland
Zip Code: 21201
UI: 20164151
Project Status: Ongoing
Record History: ('2017: Project extended to 2022.',)