Aspirin vs. heparin: which prevents clots better after cancer bone surgery?
NCT ID NCT03244020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two common blood thinners—aspirin and enoxaparin (Lovenox)—to see which works better at preventing dangerous blood clots after surgery for bone cancer or cancer that has spread to the bone. About 2,868 adults having pelvic or leg surgery for these conditions will be assigned to take one of the two drugs daily for four weeks. The goal is to find out which drug reduces clots more while causing fewer side effects like bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin and enoxaparin (a blood thinner)
- What this could lead to
- If this trial succeeds, it could show that aspirin is as effective as enoxaparin for preventing blood clots after cancer-related orthopedic surgery, potentially reducing bleeding risks and simplifying treatment.
- What could go wrong
- This is a Phase 4 trial, but it is still enrolling and results may not apply to all patients. There is a risk of bleeding or hematoma with both drugs, and the study may not find a clear difference between them.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 2,868 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patients will first be evaluated for inclusion in a master observational study with the following inclusion criteria: 1. Age ≥18 years 2. Prior or planned surgery on the pelvis or lower extremity 3. 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 4. 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: 1. Documented prior history of VTE. 2. Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery. 3. Documented allergy/adverse reaction to either of the two study drugs. 4. Presence of inferior vena cava (IVC) filter. 5. Known, diagnosed hypercoagulable state (other than malignancy). 6. Inability to receive chemical anticoagulation. 7. Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded. 8. Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason. 9. Pregnancy 10. Fear of needles that prevents administration of LMWH. 11. Inability to administer medications via needles. 12. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Cooper University Health Care
Camden, New Jersey, 08103, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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Louisiana State University Health
New Orleans, Louisiana, 70112, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Santiago Lozano-Calderon
Boston, Massachusetts, 02114, United States
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University of California Los Angeles Health
Los Angeles, California, 90404, United States
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University of Missouri-Columbia Cancer Care
Columbia, Missouri, 65201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a gentler blood thinner shield cancer patients from new clots?
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can radiation boost a personalized prostate cancer vaccine?
- Can a phone app stop deadly clots from coming back?
- Can electronic alerts and patient teaching stop deadly clots after cancer surgery?