LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology

Enrolling by invitation · Phase 4

Conditions studied: Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma, Bone Metastases, Venous Thromboembolism, Hematoma, Anticoagulant-induced Bleeding

In brief

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 facts

Study ID

NCT03244020

Run by

Massachusetts General Hospital

People needed

2868

Starts

2018-02-16

Expected to finish

2028-07-01

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Documented prior history of VTE.
• Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
• Documented allergy/adverse reaction to either of the two study drugs.
• Presence of inferior vena cava (IVC) filter.
• Known, diagnosed hypercoagulable state (other than malignancy).
• Inability to receive chemical anticoagulation.
• Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded.
• Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
• Pregnancy
• Fear of needles that prevents administration of LMWH.
• Inability to administer medications via needles.
• For patients with metastatic osseous disease, a Khorana score of ≥3.
• Pregnancy testing, via a urine or blood test, is a routine part of pre-operative laboratory testing in patients scheduled to undergo orthopaedic surgeries. Attending surgeons may also choose to exclude any patient from randomization at their discretion.

Where it is running

• University of California Los Angeles Health — Los Angeles, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Louisiana State University Health — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Santiago Lozano-Calderon — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Missouri-Columbia Cancer Care — Columbia, Missouri, United States
• Cooper University Health Care — Camden, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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