Status:
ENROLLING_BY_INVITATION
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Johns Hopkins University
University of Missouri-Columbia
Conditions:
Sarcoma
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
Lower extremity orthopaedic surgery and malignancy are both known major risk factors for venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE prophylaxis in patien...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
2868 Patients enrolled
Trial Details
Trial ID
NCT03244020
Start Date
February 16 2018
End Date
July 1 2028
Last Update
October 3 2025
Active Locations (10)
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1
University of California Los Angeles Health
Los Angeles, California, United States, 90404
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Louisiana State University Health
New Orleans, Louisiana, United States, 70112
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287