Aspirin vs LMWH for Blood Clot Prevention in Orthopaedic Cancer Surgery

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Santiago A Lozano-Calderon, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with bone or soft tissue sarcomas in the lower body who are undergoing certain surgeries. It's not for those unable to consent, pregnant, needle-phobic, with a history of blood clots or allergies to study drugs, IVC filter presence, known clotting disorders (except cancer), on full-strength aspirin or other anticoagulants pre-surgery.

Inclusion Criteria

I have had surgery for bone metastasis in my legs or pelvis.

I had surgery for bone cancer in my legs or pelvis.

I have a soft tissue sarcoma in my leg or pelvis and am receiving specific treatments.

Exclusion Criteria

Pregnancy

I cannot give myself injections.

Situation in which the attending surgeon does not feel that randomization of a subject would be appropriate

Treatment Details

Interventions

• Aspirin (Nonsteroidal Anti-inflammatory Drug)
• Enoxaparin (Anticoagulant)

Trial Overview The trial compares Aspirin (325mg) and Enoxaparin (a low molecular weight heparin) as methods to prevent blood clots after orthopaedic surgery for patients with pelvic/lower extremity cancers. The goal is to see which drug better prevents postoperative VTE.

Participant Groups

Group I: LMWH for Soft Tissue Sarcoma Experimental Treatment 1 Intervention

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

Group II: LMWH for Primary Bone Tumor Experimental Treatment 1 Intervention

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

Group III: LMWH for Metastatic Disease Experimental Treatment 1 Intervention

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

Group IV: ASA for Soft Tissue Sarcoma Experimental Treatment 1 Intervention

Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis

Group V: ASA for Primary Bone Tumor Experimental Treatment 1 Intervention

Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis

Group VI: ASA for Metastatic Disease Experimental Treatment 1 Intervention

Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis

Aspirin is already approved in Canada, China for the following indications:

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+