Actively Recruiting

Phase 2
Age: 50Years +
All Genders
NCT05775965

HIP Fracture Oral ThromboPROphylaxis (Hip PRO Pilot)

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

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.

CONDITIONS

Official Title

HIP Fracture Oral ThromboPROphylaxis (Hip PRO Pilot)

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

P

Prism S Schneider, MD, PhD

CONTACT

J

Jessica Duong, PhD

CONTACT

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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