Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery
研究概览
详细说明
All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more complicated than orally available prophylaxis, more expensive and has poor adherence.
The patients will be identified in the pre-operative admission or in post-operative orders as potentially eligible for extended prophylaxis. On the day of discharge a research assistant or a research nurse will approach the patient, provide information about the study and obtain written consent if the patient fulfills the eligibility criteria.
Each patient will be asked to take apixaban until postop day 29±1 and will be followed until postop day 90±3. The total duration of the study from first patient in to last patient out is expected to take 12 months.
At 1 week after discharge there is a telephone contact to ask about any side effects from apixaban or bleeding events or signs of thromboembolism and to answer any questions from the patient.
At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding, signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and estimate of missed doses using a standardized script. If the patient is still taking it, instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact to ask about bleeding events or signs of VTE. The study is complete for the patient. At the time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing record for apixaban, in order to verify that the patient filled the prescription.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Ontario
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Hamilton、Ontario、加拿大、L8L 2X2
- Thrombosis Service, HHS-General Hospital
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Hamilton、Ontario、加拿大、L8V 1C3
- HHS-Juravinski Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and considered at increased risk for VTE (e.g. previous history of VTE, residual cancer, slow mobilization, obesity, comorbidities).
- Written informed consent obtained.
Exclusion Criteria:
- Patient unable to take tablets, even if crushed.
- Active bleeding.
- Venous thromboembolism diagnosed during the hospitalization.
- Severe hepatic impairment (Child Pugh class C).
- Severe renal failure on dialysis or with calculated creatinine clearance <15 mL/min.
- Platelet count <50·109/L.
- Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole, voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Apixaban
apixaban for extended prophylaxis against VTE after discharge
|
apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Filled prescription
大体时间:1 week
|
Percent of included patients that have filled their prescription for apixaban
|
1 week
|
|
At least 80% adherence
大体时间:30 days
|
Percent of patients with filled prescription that have at least 80% adherence
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Venous thromboembolism post prophylaxis
大体时间:2 months
|
The event rate of venous thromboembolism during the 2 months after planned prophylaxis
|
2 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Venous thromboembolism during prophylaxis
大体时间:30 days
|
Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month
|
30 days
|
|
Rate of Major bleeding during prophylaxis
大体时间:30 days
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Major bleeding during 1st month
|
30 days
|
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Rate of Clinically relevant non-major bleeding during prophylaxis
大体时间:30 days
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Clinically relevant non-major bleeding during 1st month
|
30 days
|
|
Rate of Death during prophylaxis
大体时间:30 days
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Death during 1st month
|
30 days
|
合作者和调查者
调查人员
- 首席研究员:Sam Schulman, MD, PhD、Dr.
出版物和有用的链接
一般刊物
- Serrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18.
- Serrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26.
- Schulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1.
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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