NCT05029063招募中3 期
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,828
- 试验地点
- 11
- 主要终点
- Major VTE prevention
研究概览
简要总结
The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.
详细描述
TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind Randomized Control Trial
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
- •Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
- •Exclusion criteria:
- •CVC in place for >72 hours
- •Patient requires anticoagulation for other indications
- •Concomitant use of dual antiplatelet therapy
- •Major bleeding event in the last 4 weeks
- •Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
- •Known pregnancy or plan to become pregnant in next 3 months
- •Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
- •Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
- •Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
- •Known allergy to rivaroxaban
- •Life expectancy <3 months
- •History of condition at increased bleeding risk including, but not limited to:
- •cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
- •Chronic hemorrhagic disorder
- •Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
- •Refused or unable to obtain consent
排除标准
- 未提供
研究组 & 干预措施
Experimental
Experimental
Rivaroxaban 10mg OD
干预措施: Rivaroxaban 10 MG (Drug)
Control
Placebo Comparator
Identical Placebo 10mg OD
干预措施: Rivaroxaban 10 MG (Drug)
结局指标
主要结局
Major VTE prevention
时间窗: 90 days (± 3 days) of randomization
Number of Major VTE's in patient population
Episodes of Major Bleeding
时间窗: 90 days (± 3 days) of randomization
Number of participants who had a major bleed
次要结局
- Proximal CVC VTE(90 days (± 3 days) of randomization)
- CVC Life-span(90 days (± 3 days) of randomization)
- Distal CVC VTE(90 days (± 3 days) of randomization)
- Proximal Lower extremity DVT(90 days (± 3 days) of randomization)
- Distal Lower extremity DVT(90 days (± 3 days) of randomization)
- Number of patients who benefitted from using the experimental intervention(90 days (± 3 days) of randomization)
- Number of patients who had a fatal VTE(90 days (± 3 days) of randomization)
- Number of participants with Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses(90 days (± 3 days) of randomization)
- Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)(90 days (± 3 days) of randomization)
- Number of participants with an arterial thromboembolic event including: MI, stroke, peripheral arterial disease(90 days (± 3 days) of randomization)
- PE(90 days (± 3 days) of randomization)
- Number of patients with CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.(90 days (± 3 days) of randomization)
- Number of participants with Superficial upper or lower extremity vein thrombosis(90 days (± 3 days) of randomization)
- Number of patients with CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention(90 days (± 3 days) of randomization)
- Number of participants who passed away during the trial(90 days (± 3 days) of randomization)
- ICER(1 Year)
- EQ-5D-5L Health-related quality of life(90 days (± 3 days) of randomization)
研究者
研究点 (11)
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