NCT00708513

Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

Detailed description

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.

Conditions

• Pancreaticoduodenectomy
• Pancreatectomy
• Esophagectomy
• Gastrectomy
• Hepatectomy

Timeline

• Start date: 2003-12-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-07-02
• Last updated: 2013-10-21

Locations

2 sites across 1 country: United States