LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology

Trial details

Who runs it

Massachusetts General Hospital

Trial code

NCT03244020

Record updated

9 October 2026

Original description

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.Read full original descriptionShow less

Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology

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.

Exclusion: Documented prior history of VTE; Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery; Inability to administer medications via needles; Documented allergy/adverse reaction to either of the two study drugs; Known, diagnosed hypercoagulable state (other than malignancy); Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason; 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; Presence of inferior vena cava (IVC) filter; 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; Pregnancy; Fear of needles that prevents administration of LMWH.

Patients will first be evaluated for inclusion in a master observational study with the following inclusion criteria:; Age ≥18 years; Prior or planned surgery on the pelvis or lower extremity; Fulfills one of the following:; Cohort A: Metastatic osseous disease, undergoing: i. Endoprosthetic reconstruction ii. Curettage, cement packing, and fixation with nails, plates, and/or screws iii. Intramedullary nail fixation only b. Cohort B: Primary bone sarcoma, undergoing wide resection, amputation, or reconstruction with endoprosthesis, allograft, or allograft-prosthesis composite (APC); Cohort C: Primary soft tissue sarcoma ≥5 cm in diameter, undergoing wide resection; Anticoagulation therapy was received or is planned; In addition to fulfilling all the inclusion criteria in Part 1 of this study, participants must also not meet any of the below exclusion criteria in order to be eligible for randomization to either aspirin or LMWH.

ClinicalTrials.gov NCT03244020