JPRN-jRCTs042230058招募中2 期
Evaluating safety and outcomes of midline catheters for cancer patients receiving 5-FU chemotherapy
Taniguchi Hiroya0 个研究点目标入组 61 人开始时间: 2023年7月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients with cancer who will receive continuous intravenous 5-FU infusion for at least 4 days in the hospital.
- •(2) Patients must be at least 18 years of age (at the time of signing the consent form).
- •(3) Performance status (PS) of 0 to 1 at the time of enrollment.
- •(4) Patients who have been fully informed of the study and who have given written consent of their own free will.
排除标准
- •(1) Patients with any of the following complications.
- •1) Myocardial infarction
- •2) Congestive heart failure
- •3) Angina pectoris with subjective symptoms
- •4) Arrhythmia with subjective symptoms
- •5) Infection of skin or subcutaneous tissue of bilateral upper arms (e.g.cellulitis)
- •6) Burns or ulcers on both upper arms
- •(2)Patients with any of the following conditions.
- •1) Median nerve palsy or ulnar nerve palsy
- •2) Cerebral infarciton or hemiplegia requiring puncture insertion from the paralyzed side
- •3) Puncture insertion from the shunt limb or the limb from which the shunt is to be created is necessary
- •4) Puncture insertion from the limb from which the skin valve is to be extracted is required
- •5) Puncture insertion from the upper arm side with axillary lymph node dissection is necessary
- •(3) Patients with serious complications (interstitial pneumonia,pulmonary fibrosis,uncontrolled hypertension,uncontrolled diabetes,etc.)
- •(4) Patients with serious infections.
- •(5) Patients with dementia or other conditions that make it difficult to hold the catheter after insertion
- •(6) Patients whose bilateral brachial veins (ulnar vein and brachial vein) are anatomically difficult to insert catheters due to narrowness,collapse,thrombus occlusion,proximity to peripheral nerves,etc.
- •(7) Patients who have bilateral upper extremity range of motion impairment, such as strong contractures of the bilateral upper extremities.
- •(8) The most recent laboratory test results prior to enrollment are as follows.
- •1) Coagulation system factor PT(prothrombin time) 50% or less or INR(international normalized ratio)1.5 or more.
- •2) Platelet count less than 50,000mm3
- •(9) Patients who are taking more than 2 antithrombotic drugs.
- •(10) Pregnant or possibly pregnant.
- •(11) Other conditions that the investigator deems inappropriate for the safe conduct of this study.
研究者
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