What this study is
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.
What's being tested
- Aspirin 325mg
Intervention · DRUG
Aspirin 325 mg by mouth once daily
- Enoxaparin 40Mg/0.4mL Prefilled Syringe
Intervention · DRUG
Enoxaparin 40 mg subcutaneous injection once daily
Study details
- Official title
- Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
- Sponsor
- Massachusetts General Hospital
- Conditions
- Sarcoma · Soft Tissue Sarcoma · Bone Sarcoma · Bone Metastases · Venous Thromboembolism · Hematoma · Anticoagulant-induced Bleeding
- Enrolling
- 2,868 people
- Starts
- 2018-02-16
- Est. completion
- 2028-07-01
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openUniversity of California Los Angeles Health
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Louisiana State University Health
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Santiago Lozano-Calderon
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Missouri-Columbia Cancer Care
Columbia, Missouri, United States
Cooper University Health Care
Camden, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Study team
Sponsor
Massachusetts General Hospital
Study ID 2017P000382
Principal investigator
Santiago A Lozano-Calderon, MD, PhD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.