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HIP Fracture Oral thromboPROphylaxis (Hip PRO Pilot)

Study acronym: HIP PRO Pilot
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Mar 2025 → Mar 31, 2027
See other at-risk trials from University of Calgary

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 2025 to Mar 31, 2027 Show 5 more changesShow less
    • Trial status changed: Unknown → Recruiting
    • Study completion pushed from Mar 1, 2026 to Mar 31, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Study description expanded, about 4 words
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Notable Phase: Phase 3 to Phase 2
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to May 21, 2024
    • Study sites: 1 to 3
    v3
  4. Notable Start date: Mar 2023 to Jun 2023
    • Site contact updated
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05775965
Lead Sponsor University of Calgary
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)
Hip Fractures
Related terms Hip Fractures
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov