Actively Recruiting
HIP Fracture Oral ThromboPROphylaxis: a Pilot Randomized Controlled Trial Comparing Rivaroxaban and Aspirin for Blood Clot Prevention after Hip Fracture Surgery
Led by University of Calgary · Updated on 2025-01-14
250
Participants Needed
3
Research Sites
92 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the best oral blood thinning medications to prevent blood clots after hip fracture surgery in adults aged 50 years or older. Hip fractures in older adults are common and carry risks of serious complications like deep vein thrombosis and pulmonary embolism. This Phase 2 pilot trial aims to compare the safety and effectiveness of two oral medications, rivaroxaban and acetylsalicylic acid (ASA or aspirin), for blood clot prevention following surgery. Participants will be randomly assigned to receive either rivaroxaban 10 mg or ASA 81 mg once daily for 35 days after hip fracture surgery. The study is double-blind and multi-center, with follow-up lasting 90 days. The trial will assess recruitment feasibility, medication adherence, and participant retention, along with clinical outcomes such as symptomatic blood clots, bleeding events, and mortality. Both open and closed fractures are included, and patients on certain anti-platelet therapies may participate. During the study, participants will be monitored for complications and treatment adherence. Researchers will collect clinical data, patient-reported outcomes, and laboratory measurements related to blood clotting and bleeding. The main goal is to determine the best oral medication approach to reduce blood clot risks after hip fracture surgery while ensuring safety and ease of use for patients. Recruitment rates over the first 12 months will help guide future larger trials.
CONDITIONS
Official Title
HIP Fracture Oral ThromboPROphylaxis (Hip PRO Pilot)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 50 years or older with an acute hip fracture presenting within 24 hours of injury who require surgical treatment
- Both open and closed hip fractures are included
- Patients on single agent anti-platelet therapy such as acetylsalicylic acid or clopidogrel may participate
- Signed informed consent or surrogate consent to join the study
You will not qualify if you...
- Presentation to hospital more than 24 hours after hip fracture injury
- Pathological fractures caused by primary cancer or metastatic bone disease
- Peri-prosthetic femur fractures
- Received more than two doses of any blood clot prevention medication after surgery before joining the study
- Use of therapeutic intensity antithrombotic therapy (like LMWH, warfarin, DOACs, clopidogrel/ticagrelor, or chronic aspirin use) in the three months before hip fracture
- Known inherited bleeding or clotting disorders such as factor V Leiden or protein C deficiency
- Intracranial hemorrhage requiring multiple brain scans or surgery
- Allergy or contraindication to aspirin including recent gastrointestinal ulcers or very low platelet counts
- Allergy or contraindication to rivaroxaban including acute kidney failure
- Unable or unwilling to provide consent or complete follow-up
- Under 50 years old
- Multiple injuries requiring prolonged or delayed blood clot prevention
- Unable to attend follow-up visits
- Currently incarcerated or in a correctional facility
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 5A1
Actively Recruiting
2
Royal Columbian Hospital
New Westminster, British Colombia, Canada, V3L 0E4
Not Yet Recruiting
3
The Ottawa Hospital
Ottawa, Ontario, Canada
Not Yet Recruiting
Research Team
P
Prism S Schneider, MD, PhD
J
Jessica Duong, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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