NCT02792764已完成不适用
A Prospective, Multi-centered Study to Assess the Complication Rates of Oncology Patients Accessed With Peripheral Intravenous Lines Versus Implantable Ports for Chemotherapy Administration
C. R. Bard2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.
研究概览
简要总结
This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 21 years
- •Subject is currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a PIV
- •Subject had a chemotherapy regimen consisting of a vesicant and/or irritant
- •Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative
排除标准
- •Subject has/had an implanted non Bard PORT
结局指标
主要结局
The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.
时间窗: Through end of chemotherapy, up to 3 years
Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications
次要结局
- The average number of accesses during course of treatment (i.e. - chemotherapy administration, CTs, blood draws, TPN, etc.)(Through end of chemotherapy, up to 3 years)
- The rate of Vascular Access Device conversion from Peripheral IV to PORT(Through end of chemotherapy, up to 3 years)
- The average time of vascular access device conversion from Peripheral IV to PORT(Through end of chemotherapy, up to 3 years)
研究者
研究点 (2)
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