Clinical trial · Interventional
Enoxaparin Versus Placebo for Venous Thromboembolism Prevention in Low Risk Cancer Patients After Surgical Procedures: a Randomized, Double Blind, Placebo Controlled Clinical Trial Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding was not received.
Summary
Brief summary (as posted)
Post-surgical bleeding is a major source of morbidity in cancer patients, and ramifications can include need for transfusion, increased length of hospital stay, unexpected return to the operating room, or even death. Current guidelines support that all cancer patients who require surgical procedures receive post-operative blood thinners to minimize risk for blood clots in the legs or lungs, known as venous thromboembolism (VTE), but these medications have an unfavorable risk/benefit relationship among patients at low risk for VTE. The proposed work will pilot a randomized, double blind, placebo controlled trial to critically examine the role of de-implementation of current guidelines that mandate blood thinning medications among cancer patients at low risk for VTE who require surgical procedures; the pilot trial will allow optimization of the design of a future pragmatic multicenter trial, which ultimately would maximize patient safety after surgical procedures for cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding as Surgical Complication (Treatment) | — | UNRESOLVED | — |
| Deep Venous Thrombosis | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Receipt of enoxaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Enoxaparin 40mg once daily
- description
- All patients will have enoxaparin prophylaxis or placebo initiated at 8 hours after surgery. Prophylaxis or placebo will be provided every 24 hours and will be continued for the duration of inpatient stay.
- interventionNames
- Drug: Receipt of enoxaparin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- All patients will have enoxaparin prophylaxis or placebo initiated at 8 hours after surgery. Prophylaxis or placebo will be provided every 24 hours and will be continued for the duration of inpatient stay.
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- 90-day symptomatic venous thromboembolism
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The five most common cancers in the United States, based on National Cancer Institute data, include breast, lung, urologic (prostate and bladder), colorectal, and melanoma. As such, we will conduct our work in these patient populations to make our results as generalizable as possible. Inclusion criteria will include: * Adult (age≥18) patients * Surgical procedure under general anesthesia * Caprini score ≤6 * Expected post-operative stay will be at least 23 hours (these are the patients for whom current guidelines mandate provision of chemical prophylaxis, but for whom current clinical practice demonstrates equipoise.) Exclusion criteria will include: * Contraindication to use of enoxaparin * Intracranial bleeding/stroke * Hematoma or bleeding disorder * Heparin-induced thrombocytopenia positive * Creatinine clearance ≤ 30mL/min * Serum creatinine \>1.6mg/dL * Planned epidural anesthesia * Scheduled return to the operating room within 90 days will be a criteria for exclusion-we will only consent patients for whom a single operative procedure is scheduled to avoid interruption of post-operative anticoagulation or placebo for a second operative procedure * Patients with platelet count \<50k/uL will be excluded only with "a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium," per the enoxaparin package insert.
References
Publications (0)
Data not yet available