Assessment of a Power Injectable vs. a Non-Power Injectable, Upper Arm, Totally Implanted Venous Access Devices for Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
研究概览
简要总结
Patients with cancer often require intravenous chemotherapy for long periods of time.
Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins.
A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing.
Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.
详细描述
Hypothesis:
The null hypothesis envisions both devices performing similarly in regards to chemotherapy and complications. However, the power injectable population will experience the high flow, large volume injections, may experience complications of injection extravasation and port damage due to the more vigorous injection parameters.
Trial Objectives:
- To prospectively assess the functionality and complications of a power injectable vs. a non-power injectable TIVAD in a cohort of breast cancer patients requiring intravenous chemotherapy. The TIVAD will be randomly assigned to each patient.
- Assess quality of life for subjects who have the two different TIVADs.
- Facilitate device selection for future cancer patients requiring chemotherapy.
We will perform a randomized, prospective clinical trial of patients with cancer to compare a non-power injectable port, Cook Vital Mini Port (Cook Canada, Mississauga, ON), with a power injectable port, the AngioDynamics Smart Port CT Mini (AngioDynamics Inc., Manchester, GA, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included.
排除标准
- •• Those under the age of 16 years;
- •Those with uncorrectable blood clotting disorder;
- •Pregnant women, as they will not be candidates for chemotherapy;
- •Any person with an active infection or immunocompromised state;
- •Those on oral or intravenous antibiotics on the day of TIVAD implantation.
结局指标
主要结局
Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
时间窗: 2 years after insertion
Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence
次要结局
- Venous Thrombosis(2 years after implantation)
- Quality of Life Related to Port(2 years after implantation)
- Infection(2 years after implantation)
研究者
Brent Burbridge
M.D.
University of Saskatchewan