LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology

NCT03244020 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2017P000382
• Study Type: interventional
• Target: 2,868
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Sarcoma; Soft Tissue Sarcoma; Bone Sarcoma; Bone Metastases; Venous Thromboembolism; Hematoma; Anticoagulant-induced Bleeding

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism

  Deep venous thrombosis; pulmonary embolus

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

Secondary Outcomes (4)

• Hematoma formation

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

• Complication requiring return to operating room

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

• Early chemoprophylaxis stop

  Up to 4 weeks post operatively

• Infection

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

Study Arms (6)

LMWH for Soft Tissue Sarcoma

EXPERIMENTAL

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

Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe

ASA for Soft Tissue Sarcoma

EXPERIMENTAL

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

Drug: Aspirin 325mg

LMWH for Primary Bone Tumor

EXPERIMENTAL

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

Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe

ASA for Primary Bone Tumor

EXPERIMENTAL

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

Drug: Aspirin 325mg

LMWH for Metastatic Disease

EXPERIMENTAL

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

Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe

ASA for Metastatic Disease

EXPERIMENTAL

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

Drug: Aspirin 325mg

Interventions

Aspirin 325mg DRUG

Aspirin 325 mg by mouth once daily

Also known as: ASA

ASA for Metastatic Disease; ASA for Primary Bone Tumor; ASA for Soft Tissue Sarcoma

Enoxaparin 40Mg/0.4mL Prefilled Syringe DRUG

Enoxaparin 40 mg subcutaneous injection once daily

Also known as: Lovenox

LMWH for Metastatic Disease; LMWH for Primary Bone Tumor; LMWH for Soft Tissue Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Prior or planned surgery on the pelvis or lower extremity
• Fulfills one of the following:
• a. 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).
• c. Cohort C: Primary soft tissue sarcoma ≥5 cm in diameter, undergoing wide resection
• Anticoagulation therapy was received or is planned.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Johns Hopkins University: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (10)

University of California Los Angeles Health

Los Angeles, California, 90404, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Louisiana State University Health

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Santiago Lozano-Calderon

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Missouri-Columbia Cancer Care

Columbia, Missouri, 65201, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms; Venous Thromboembolism; Hematoma

Interventions

Aspirin; Enoxaparin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Santiago A Lozano-Calderon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Model Details: Three separate patient categories are being investigated in this trial. All patients are undergoing pelvic and/or lower extremity surgery for one of three possible conditions: 1) soft tissue sarcoma; 2) primary bone sarcoma; 3) metastatic bone disease. Within each of these groups, patients will be randomized to either aspirin or low molecular weight heparin (enoxaparin) for venous thromboembolism prophylaxis post operatively.

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: August 9, 2017
• Study Start: February 16, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)