跳至主要内容
临床试验/NCT00708513
NCT00708513已完成不适用

Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations

University of Louisville2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2003年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert C. Martin

MD

University of Louisville

研究点 (2)

Loading locations...

相似试验