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Aspirin vs. heparin: which prevents clots better after cancer bone surgery?

NCT ID NCT03244020

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,868 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cooper University Health Care

    Camden, New Jersey, 08103, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Louisiana State University Health

    New Orleans, Louisiana, 70112, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Santiago Lozano-Calderon

    Boston, Massachusetts, 02114, United States

  • University of California Los Angeles Health

    Los Angeles, California, 90404, United States

  • University of Missouri-Columbia Cancer Care

    Columbia, Missouri, 65201, United States

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