Oral Blood Thinners for Hip Fracture
(HIP PRO Pilot Trial)
Trial Summary
What is the purpose of this trial?
As our Canadian population ages, hip fractures in these older adults are becoming very common. The best treatment for the majority of these injuries is urgent treatment with surgery. However, the hip fracture itself, the surgery required, and the immobility following these injuries are all risk factors for developing blood clots in the legs (deep vein thrombosis or DVT) and blood clots in the lungs (pulmonary embolism or PE). These complications are a common cause of death in patients with hip fractures and often result in prolonged medical treatment and hospital stays. Patients with hip fractures who require surgery are traditionally given injectable blood thinners to help prevent blood clots; however, these medications are costly, may not be tolerated well, and can be difficult to take, as prescribed. Oral blood thinning medications are being used more commonly, but it is unknown which of these medications is the most effective in preventing blood clots in patients after a hip fracture. Thrombelastography (TEG) technology uses a small sample of blood to evaluate a person's clotting ability. Our research has used TEG technology to evaluate blood clotting risk after hip fracture surgery and the investigators have found that platelets may play an important role in abnormal blood clotting after a hip fracture. The investigators have also shown that acetylsalicylic acid (ASA or Aspirin) may help reduce the abnormal platelet hyperactivity associated with blood clotting. This medication warrants investigation for blood clot prevention after hip fracture. The investigators propose to directly compare different oral medication regimens after hip fracture surgery, in order to determine which is safest and most effective in preventing blood clots. Our multi-disciplinary research team includes physicians, surgeons, and scientists with experience evaluating different medications for blood clot prevention. Our results will help determine the best medical treatment for preventing DVT and PE, which will benefit patients with hip fractures worldwide.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients who have been on certain blood thinners like Warfarin, DOACs, or chronic aspirin use in the three months before the hip fracture. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
What data supports the effectiveness of the drugs Acetylsalicylic acid (ASA) and Rivaroxaban for hip fracture?
Research shows that both aspirin (ASA) and rivaroxaban are effective in preventing blood clots after surgeries like knee and hip replacements, which are similar to hip fracture surgeries. They have been found to prevent conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE) without significantly increasing bleeding risks.12345
Is it safe to use oral blood thinners like aspirin and rivaroxaban for hip fracture?
How is the drug for hip fracture different from other treatments?
This treatment combines low-dose aspirin (acetylsalicylic acid, ASA) and rivaroxaban, both of which are anticoagulants (blood thinners) that help prevent blood clots. Unlike some other treatments, this combination is taken orally and is specifically studied for its effectiveness in preventing blood clots after hip fracture surgery, offering a potentially convenient and effective option.134610
Research Team
Prism Schneider, MD
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for adults aged 50 or older who have a hip fracture that needs surgery and got to the hospital within 24 hours of injury. They can be on low-dose anti-platelet therapy like aspirin. People with cancer-related fractures, those who can't follow up, took lots of blood thinners post-injury, or have certain bleeding/clotting disorders can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either rivaroxaban 10 mg daily or ASA 81 mg daily for 35 days post hip fracture surgery
Follow-up
Participants are monitored for safety and effectiveness, including VTE and bleeding complications, with assessments at various intervals
Long-term Follow-up
Participants are monitored for mortality and healthcare costs over a 12-month period
Treatment Details
Interventions
- Acetylsalicylic acid (ASA) 81mg Oral Tablet
- Rivaroxaban 10mg
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator