Oral blood thinners for preventing blood clots after hip fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: prism.schneider@albertahealthservices.ca
• Phone: (403) 944-4518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.