Low Molecular Weight Heparin (LMWH) vs Aspirin for Venous Thromboembolism (VTE) Prophylaxis in Orthopaedic Oncology

• Status: Enrolling by invitation
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital
• Treatments: Aspirin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Patients with metastatic osseous disease of the lower extremities or pelvis treated with endoprosthetic reconstruction, curettage and cement packing with intramedullary nail fixation and/or plate and screws, or intramedullary nail fixation only.

• Patients with primary bone sarcomas of the lower extremities or pelvis treated with wide resections and amputations or reconstruction with endoprosthesis, allografts, or allograft prosthetic composites.

• Patients with soft tissue sarcomas of the lower extremities or pelvis measuring more than 8 cm in size, deep to the fascia levels, treated with preoperative or postoperative radiation, plus/minus preoperative and/or postoperative chemotherapy, receiving surgery with wide margins, followed by primary closure, closure with free or rotational, and/or skin graft. (478 patients per arm)

Exclusion Criteria:

• Documented prior history of VTE

• Pre-operative use of therapeutic or prophylactic chemical anti-coagulation at the time of surgery (not including ASA 81 mg)

• Documented allergy/adverse reaction to either of the two study drugs

• Presence of an inferior vena cava (IVC) filter

• Known diagnosed hypercoagulable state (other than malignancy)

• Inability to receive chemical anticoagulation

• Pre-operative use of full strength aspirin 325 milligrams (mg) daily

• Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.

• Pregnancy