A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Primary Feasibility Outcome - Number of Participants Recruited Per Month
研究概览
简要总结
Purpose of the Pilot Trial:
To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.
详细描述
Design:
This is a pilot interventional study to be conducted at 2 Canadian Centres. The Ottawa Hospital and Juravinski Hospital. It is an open label randomized controlled trial.
Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups.
Rivaroxaban 10mg by mouth daily x 90 (+/- 3) days OR Standard of Care
Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days or until CVC is removed. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days). Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days.
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
- •1.Patients 18 years of age or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
排除标准
- •CVC in place for >72 hours
- •Patient requires anticoagulation for other indication
- •Concomitant use of dual antiplatelet therapy
- •Major bleeding event in the last 6 weeks
- •Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
- •Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
- •Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
- •Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
- •Known thrombocytopenia < 50x 109/L (in the previous 3 months)
- •Allergy to rivaroxaban
- •Life expectancy <6 months
- •History of condition at increased bleeding risk including, but not limited to:
- •Major surgical procedure or trauma within 30 days before the randomization visit
- •Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
- •History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
- •Chronic hemorrhagic disorder
- •Known intracranial neoplasm, arteriovenous malformation, or aneurysm
- •Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
- •Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
- •Geographic inaccessibility
- •Refused or unable to obtain consent
研究组 & 干预措施
Rivaroxaban Thromboprophylaxis
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
干预措施: Rivaroxaban 10 MG (Drug)
结局指标
主要结局
Primary Feasibility Outcome - Number of Participants Recruited Per Month
时间窗: 12 months
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
次要结局
- Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy(90 days)