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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
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.
Details
| Lead sponsor | University of Utah |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2021-07 |
| Completion | 2023-06 |
Conditions
- Venous Thromboembolism
- Bleeding as Surgical Complication (Treatment)
- Deep Venous Thrombosis
- Pulmonary Embolism
Interventions
- Receipt of enoxaparin
- Placebo
Primary outcomes
- 90-day symptomatic venous thromboembolism — 90 days
Symptomatic VTE will include 1) any deep venous thrombosis event, including upper limb, lower limb, or central veins (inferior vena cava, portal vein, etc) that is confirmed with imaging including but not limited to duplex ultrasound, CT scan, or venogram and/or 2) any pulmonary embolus event that is confirmed with imaging, including but not limited to CT scan, venogram, or V/Q scan and/or 3) any autopsy-proven VTE and/or 4) 90-day mortality in which VTE cannot be excluded (eg PEA arrest with no autopsy performed). - 90-day clinically relevant bleeding — 90 days
1. Symptomatic or clinically overt bleeding that is associated with one or more of a) transfusion of ≥2 units of blood, b) hemoglobin decrease of \>2g/dL, or c) need for reoperation or invasive intervention such as wound opening or percutaneous drainage procedure and/or 2. Symptomatic or clinically overt bleeding at a critical anatomic site, including intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or within a muscle compartment causing compartment syndrome 3. Fatal bleeding, in which the bleeding event directly contributes to death or causes clinical deterioration leading to death 4. In addition, we include clinically overt bleeding in which the surgeon chooses to discontinue study drug (enoxaparin versus placebo) prior to hospital discharge as a bleeding event.