Maintenance Optimization of the Fully Implanted Venous Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.
The fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.
The maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.
The objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.
Participants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients over 18 years of age.
- •Cancer patients, undergoing placement of CVCTI for chemotherapy, in follow-up, who finished chemotherapy up to a maximum period of 10 weeks.
- •Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- •Evidence of signed and dated informed consent indicating that the patient has been informed of all relevant aspects of the study and agrees to participate.
排除标准
- •Presence of metastases or any other condition that may be an indication for intravenous treatments or additional chemotherapy regimens
- •History of CVCTI-related adverse events during the treatment phase
- •Patients on anticoagulant medication
- •History of thrombophilia
- •Pregnancy/Breastfeeding
结局指标
主要结局
Number of Adverse Events
时间窗: Time since screening until follow-up visit (on average 20 months)
The occurrence of any adverse event related to the use of the CVCTI, thus allowing to assess the difference between the 2 groups with as much data as possible.
次要结局
- Occurence of AE related with infectious complications(Time since screening until follow-up visit (on average 20 months))
- Occurence of AE related with thrombotic complications(Time since screening until follow-up visit (on average 20 months))