NCT03244020Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2868 (estimated)
- First submitted
- 5 Aug 2017
- Start date
- 16 Feb 2018
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Sarcoma
- NCT number
- NCT03244020
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2868
- From 16 Feb 2018 to the primary completion date, 31 Dec 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented prior history of VTE.
- Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
- Inability to administer medications via needles.
Other illness
- Documented allergy/adverse reaction to either of the two study drugs.
- Known, diagnosed hypercoagulable state (other than malignancy).
- Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
Lab values
- 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.
Other
- Presence of inferior vena cava (IVC) filter.
- 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.
- Pregnancy
- Fear of needles that prevents administration of LMWH.
Criteria the registry did not label
- Patients will first be evaluated for inclusion in a master observational study with the following inclusion criteria:
- Age ≥18 years
- Prior or planned surgery on the pelvis or lower extremity
- Fulfills one of the following:
- 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).
- Cohort C: Primary soft tissue sarcoma ≥5 cm in diameter, undergoing wide resection
- Anticoagulation therapy was received or is planned.
- In addition to fulfilling all the inclusion criteria in Part 1 of this study, participants must also not meet any of the below exclusion criteria in order to be eligible for randomization to either aspirin or LMWH.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Santiago Lozano-Calderon Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cooper University Health Care Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Missouri-Columbia Cancer Care Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| University of California Los Angeles Health Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Louisiana State University Health Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.