Comparison of Apixaban Versus Enoxaparin as Venous Thromboembolism Prophylaxis After Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. The main questions it aims to answer are:
- Are patients equally adherent to apixaban as they are enoxaparin? Why or why not?
- Do patients prefer apixaban or enoxaparin?
- What is the typical patient cost to take apixaban vs enoxaparin after surgery?
Participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. They will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Able to communicate in English over the phone
- •Male or female, age >18 years
- •Diagnosed with biopsy-proven, urothelial cell carcinoma (any T stage, N0-1, M0) with plan for radical cystectomy with urinary diversion and concurrent pelvic lymph node dissection as treatment
排除标准
- •Preoperative use of a therapeutic dose of anticoagulant (this notably does not exclude patients taking antiplatelet agents)
- •Failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection
- •Failure to be discharged by post-operative day 14
- •Failure to receive a script for enoxaparin or apixaban.
- •Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)
研究组 & 干预措施
Enoxaparin
Participants randomized to receive script for prophylactic dose of enoxaparin. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves.
干预措施: enoxaparin (Other)
Apixaban
Participants randomized to receive script for prophylactic dose of apixaban. Dosing will be done based on clinical providers (pharmacists) according to usual care. Participants will fill the script themselves.
干预措施: apixaban (Other)
结局指标
主要结局
Adherence
时间窗: Day of discharge to post-operative day 30
proportion of days covered
次要结局
- VTE rate(Day of discharge to post-operative day 90)
- Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)(Day of discharge to post-operative day 30)
- Cost(Day of discharge to post operative day 90)
- Reasons for non-adherence(Day of discharge to post-operative day 30)
- Bleeding rate(Day of discharge to post-operative day 90)
研究者
Katharine Michel
Resident
Abramson Cancer Center at Penn Medicine