Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration
研究概览
简要总结
The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.
详细描述
Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.
This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.
This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
- •Subject is ≥ 18 years of age.
- •Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.
排除标准
- •Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- •Subject is < 18 years of age.
- •Subject or Subject's LAR did not sign IRB-approved informed consent form.
结局指标
主要结局
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration
时间窗: Hospital discharge
次要结局
未报告次要终点
研究者
Robert C. Martin
MD
University of Louisville
