Oral blood thinners for preventing blood clots after hip fractures

HIP Fracture Oral ThromboPROphylaxis: a Pilot Randomized Controlled Trial (Hip PRO Pilot)

This study is testing if oral blood thinners can help prevent blood clots in people aged 50 and older who have had hip fractures and need surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University of Calgary (Academic / other)
• Locations: 3 sites (Calgary, Alberta and 2 other locations)
• Trial ID: NCT05775965 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of oral blood thinners, specifically rivaroxaban and acetylsalicylic acid (ASA), in preventing blood clots in patients aged 50 and older who have suffered an acute hip fracture requiring surgery. The study aims to compare these oral medications to traditional injectable blood thinners, addressing issues of adherence and tolerance. Participants will be recruited from multiple hospitals across Canada, and the trial will focus on those presenting within 24 hours of their injury. The goal is to determine the optimal thromboprophylaxis strategy to reduce the risk of life-threatening complications following hip fracture surgery.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 years or older with an acute hip fracture requiring surgical treatment.

Not a fit: Patients with delayed presentation of more than 24 hours or those with pathological fractures due to cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and patient-friendly method for preventing blood clots in older adults after hip fractures.

How similar studies have performed: Previous studies have shown promising results with oral anticoagulants in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Patients aged 50 years or older with an acute hip fracture (presentation to hospital within 24 hours of injury) that requires surgical treatment will be approached for inclusion in the study:

1. Age ≥ 50 years with a hip fracture (AO-OTA classification 31-A1-A3 and 31-B1-B3) amenable to surgical treatment (presentation to hospital within 24 hours of injury). Patients with additional injuries will be included and any additional injuries will be documented.
2. Both open and closed fractures will be included, and open fractures will be documented.
3. Patients on single agent anti-platelet therapy (i.e., acetylsalicylic acid or clopidogrel) will be included.
4. Signed informed consent or surrogate consent to participate in study.

Exclusion Criteria:

1. Delayed presentation (over 24 hours between hip fracture and presentation to hospital).
2. Pathological fractures secondary to primary cancer or metastatic bone disease.
3. Peri-prosthetic femur fractures.
4. Received more than two doses of any thromboprophylaxis agent post-operatively, prior to randomization.
5. Pre-hospital therapeutic intensity antithrombotic therapy, including LMWH, Warfarin, DOACs, clopidogrel/ticagrelor, or chronic ASA use of any dose in the three months prior to hip fracture.
6. Known inherited bleeding or clotting disorder (factor V Leiden gene mutation, prothrombin gene mutation, protein C or protein S deficiency, antithrombin deficiency).
7. Intracranial hemorrhage requiring serial CT scans of the brain and/or surgical intervention.
8. Contraindication to ASA use (allergy, documented gastrointestinal ulcer within the past year, severe thrombocytopenia \[platelet count \<50 x109/L at the time of hospital admission\]).
9. Contraindication to rivaroxaban use (allergy, acute renal failure \[CrCl \<30 mL/min\]).
10. Participant or surrogate unable to or unwilling to provide consent or complete follow-up. Or surrogate consent not available.
11. Under age 50 years (more likely high energy, multiple injuries).
12. Multiply injured patients who require prolonged thromboprophylaxis or delayed thromboprophylaxis initiation.
13. Patient unable to attend follow-up visits.
14. Currently incarcerated, at a correctional facility.

Where this trial is running

Calgary, Alberta and 2 other locations

• Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
• Royal Columbian Hospital — New Westminster, British Colombia, Canada (Not_yet_recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Prism S Schneider, MD, PhD — University of Calgary
• Study coordinator: Prism S Schneider, MD, PhD

Conditions Hip Fractures