LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology

Part of paid clinical trials in Los Angeles, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT03244020
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Anticoagulant-induced Bleeding
  • Bone Metastases
  • Bone Sarcoma
  • Hematoma
  • Sarcoma
  • Soft Tissue Sarcoma
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin 325mg — DRUG
    Aspirin 325 mg by mouth once daily
  • Enoxaparin 40Mg/0.4mL Prefilled Syringe — DRUG
    Enoxaparin 40 mg subcutaneous injection once daily

Study Details

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.

Key Dates

Start date
Feb 16, 2018
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
2,868 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: LMWH for Soft Tissue Sarcoma
    Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
  • Experimental: ASA for Soft Tissue Sarcoma
    Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis
  • Experimental: LMWH for Primary Bone Tumor
    Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
  • Experimental: ASA for Primary Bone Tumor
    Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis
  • Experimental: LMWH for Metastatic Disease
    Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
  • Experimental: ASA for Metastatic Disease
    Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis

Primary Outcome Measure

Venous thromboembolism [ Time Frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California Los Angeles HealthLos AngelesCalifornia90404-
Moffitt Cancer CenterTampaFlorida33612-
Louisiana State University HealthNew OrleansLouisiana70112-
Johns Hopkins UniversityBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Santiago Lozano-CalderonBostonMassachusetts02114-
University of Missouri-Columbia Cancer CareColumbiaMissouri65201-
Cooper University Health CareCamdenNew Jersey08103-
Cleveland ClinicClevelandOhio44195-

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University of California Los Angeles Health· Los Angeles, CAMoffitt Cancer Center· Tampa, FLLouisiana State University Health· New Orleans, LAJohns Hopkins University· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MA

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