Aspirin vs LMWH for Blood Clot Prevention in Orthopaedic Cancer Surgery

Enrolling by invitation at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must be taking: Anticoagulants

Must not be taking: Full-strength aspirin

Disqualifiers: VTE history, Hypercoagulable state, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether aspirin or low molecular weight heparin (LMWH, known as Enoxaparin) better prevents blood clots after certain cancer-related bone or soft tissue surgeries. Participants will either take aspirin or receive LMWH to assess which reduces the risk of post-surgery blood clots. The trial seeks individuals who have undergone or plan to undergo surgery on the pelvis or lower limbs due to metastatic bone disease, primary bone sarcoma, or large soft tissue sarcoma. As a Phase 4 trial, this research explores how these FDA-approved treatments benefit more patients, providing an opportunity to contribute to medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain anticoagulants or full-strength aspirin before surgery. It's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Research has shown that aspirin is safe for preventing blood clots after surgery for bone and soft tissue cancers. One study found that both high and low doses of aspirin are well-tolerated by patients who have undergone joint replacement surgery, suggesting it is likely safe for other types of bone surgeries as well. However, patients with primary bone cancer who use medication to prevent clots may face a higher risk of wound problems.

Regarding enoxaparin, a study demonstrated that it does not significantly increase bleeding when used to prevent blood clots after surgeries for bone or soft tissue cancers. This makes it a generally safe choice for clot prevention, although patients undergoing surgery for these cancers are at a higher risk of developing blood clots overall.

Both treatments are well-researched and commonly used. It is important to discuss any concerns with a doctor to choose the best option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer potentially simpler and more patient-friendly options for preventing blood clots after orthopedic cancer surgery. Unlike standard options like warfarin or heparin, which often require regular blood monitoring and adjustments, aspirin is an oral medication that's easy to take. Enoxaparin, on the other hand, is a low molecular weight heparin given via a convenient prefilled syringe, offering a more stable and predictable anticoagulant effect without frequent monitoring. These characteristics might make both aspirin and enoxaparin preferable for patients, potentially improving adherence and outcomes in preventing venous thromboembolism (VTE) after surgery.

What evidence suggests that this trial's treatments could be effective for VTE prevention in orthopaedic cancer surgery?

This trial will compare the effectiveness of aspirin and low molecular weight heparin (LMWH), such as enoxaparin, in preventing venous thromboembolism (VTE) in patients undergoing orthopedic cancer surgery. Studies have shown that both aspirin and LMWH effectively prevent VTE, which occurs when blood clots form in veins. Participants in this trial will be randomized to receive either aspirin or LMWH, based on their specific surgical context. Aspirin is a good option for preventing VTE, especially after surgeries for bone cancer. Research also shows that LMWH effectively lowers the risk of VTE in similar surgeries. Guidelines based on strong evidence support using both treatments in these high-risk situations. While both are effective, the choice often depends on individual patient needs and specific surgical details. ^{1 6 7 8 9}

Who Is on the Research Team?

Santiago A Lozano-Calderon, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

I have a diagnosed condition that causes abnormal blood clotting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either aspirin or low molecular weight heparin (LMWH) for VTE prophylaxis after pelvic/lower extremity orthopaedic oncology surgery

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness, including incidence of VTE, hematoma formation, and wound complications

Up to 6 months

Monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Enoxaparin

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.

How Is the Trial Designed?

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 European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

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

Approved in United States as Aspirin for:

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

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+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

Published Research Related to This Trial

In a study of 85,938 patients undergoing hip or knee arthroplasty, aspirin was associated with significantly lower odds of bleeding complications compared to enoxaparin, making it a safer option for thromboprophylaxis.

While rivaroxaban also showed a trend toward increased bleeding compared to aspirin, the differences were not statistically significant, suggesting that aspirin may be the preferred choice for minimizing bleeding risks post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of bleeding risk with rivaroxaban, enoxaparin, and aspirin following total joint arthroplasty or revision. Watts, PJ., Kopstein, M., Harkness, W., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29206790/

Aspirin for Prophylaxis Against Venous Thromboembolism ... Aspirin may be a suitable and effective option for VTE chemoprophylaxis in patients treated with orthopaedic oncologic surgery, especially those diagnosed with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03244020

NCT03244020 | LMWH Vs Aspirin for VTE Prophylaxis in ... The specific aim of this study is to compare the post operative incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolus (PE) between patients ...

3. clinicaltrial.be clinicaltrial.be/en/details/177543?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic ... Lower extremity orthopaedic surgery and malignancy are both known major risk factors for venous thromboembolism (VTE). Guidelines from high quality data ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/jso.27997

Is Aspirin Safe for Thromboprophylaxis After Surgery ... Therefore, this study aimed to compare VTE rates among patients receiving enoxaparin, apixaban, rivaroxaban, or aspirin (ASA). Methods. The ...

5. semanticscholar.org semanticscholar.org/paper/8ed87a76ef9be21911e21ae7c93b50f4cbc5915c

Aspirin for Prophylaxis Against Venous Thromboembolism After ... Aspirin may be a suitable and effective option for VTE chemoprophylaxis in patients treated with orthopaedic oncologic surgery, especially those diagnosed ...

6. aoj.amegroups.org aoj.amegroups.org/article/view/7413/html

Venous thromboembolism in musculoskeletal oncology surgery A prospective cross-over study of patients undergoing primary total joint arthroplasty (TJA) demonstrated aspirin, both high dose and low dose, is a safe and ...

7. researchgate.net researchgate.net/publication/386172616_Is_Aspirin_Safe_for_Thromboprophylaxis_After_Surgery_for_Lower_Extremity_Neoplastic_Pathologic_Fractures

Is Aspirin Safe for Thromboprophylaxis After Surgery ... Methods: This study was a retrospective review of patients diagnosed with a primary malignant soft-tissue or bone tumor or metastatic carcinoma. Demographic ...

8. journals.lww.com journals.lww.com/jbjsjournal/fulltext/2022/03161/recommendations_from_the_icm_vte__oncology.6.aspx

Recommendations from the ICM-VTE: Oncology The risk of wound complications increased significantly in patients with primary bone sarcoma who received chemical prophylaxis (OR 2.21, 95% CI ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8039818/

Surgical outcomes of metastatic bone tumors in the ... The 1-year overall survival rate was 59%, and the median survival time after surgery was 20 months. Primary tumor, visceral metastasis, and surgical procedure ...