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Nonsteroidal Anti-inflammatory Drug

Aspirin vs LMWH for Blood Clot Prevention in Orthopaedic Cancer Surgery

Phase 4

Waitlist Available

Led By Santiago A Lozano-Calderon, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with metastatic osseous disease of the lower extremities or pelvis treated with specific surgical methods

Patients with primary bone sarcomas of the lower extremities or pelvis treated with specific surgical methods

Must not have

Inability to administer medications via needles themselves

Known diagnosed hypercoagulable state (other than malignancy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to compare the rates of VTE between patients taking aspirin and those taking LMWH after pelvic/lower extremity orthopaedic surgery for cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include bleeding risks and hematoma formation due to the blood-thinning nature of both Aspirin and Enoxaparin. There may also be local reactions at injection sites for Enoxaparin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot give myself injections.

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I have a diagnosed condition that causes abnormal blood clotting.

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I take 325 mg of aspirin daily before surgery.

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I cannot take blood thinners.

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I cannot give consent myself due to a mental condition.

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I have a history of blood clots.

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I am allergic to one of the drugs used in this study.

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I am taking blood thinners other than low-dose aspirin for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Venous thromboembolism

Secondary study objectives

Complication requiring return to operating room

Early chemoprophylaxis stop

Communicable Diseases

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: LMWH for Soft Tissue SarcomaExperimental Treatment1 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 TumorExperimental Treatment1 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 DiseaseExperimental Treatment1 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 SarcomaExperimental Treatment1 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 TumorExperimental Treatment1 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 DiseaseExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin 325mg

2019