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

• Status: Withdrawn
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Enoxaparin

Criteria

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.