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LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Aspirin 325mg (Drug), Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug) to Aspirin 325mg (Drug), Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug) Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 3 of 4 entries · Site details revised at 1 of 10 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised at 1 of 10 sites
  2. Collaborators expanded, about 6 wordsv11 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 1434 to 2868 Study sites: 1 to 10v10 Show 1 more changeShow less
    • Study sites: 1 to 10
  4. Re-verified, no change to tracked fieldsv9
  5. Primary completion date: Dec 31, 2023 to Dec 31, 2027 Completion date: Jul 1, 2024 to Jul 1, 2028 · Eligibility criteria expanded, about 61 words · Study title shortened, about 6 wordsv8 Show 3 more changesShow less
    • Completion date: Jul 1, 2024 to Jul 1, 2028
    • Eligibility criteria expanded, about 61 words
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 27 words Secondary endpoints: details revised at 4 of 4 entries · Collaborators shortened, about 9 wordsv7 Show 2 more changesShow less
    • Secondary endpoints: details revised at 4 of 4 entries
    • Collaborators shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  2. 3 versions Re-verified since Feb 23, 2021, no change to tracked fieldsv4-v6
  3. Enrollment target: 2868 to 1434v3
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Oct 1, 2017 to Feb 16, 2018 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 1, 2017 to Feb 16, 2018
    • Study sites: 0 to 1
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity orthopaedic surgery for malignancy are lacking, however, as compared to the data and guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture surgery. In this clinical trial, our specific aim is to compare the post operative incidence of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic oncology procedures.
Trial Details
NCT Number NCT03244020
Lead Sponsor Massachusetts General Hospital
Collaborators: Johns Hopkins University, University of Missouri-Columbia
Conditions Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma, Bone Metastases, Venous Thromboembolism, Hematoma, Anticoagulant-induced Bleeding
Enrollment 2,868 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov