Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Completed

• Conditions: Pancreaticoduodenectomy; Esophagectomy; Gastrectomy; Hepatectomy; Pancreatectomy

• Registration Number: NCT00708513
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
2. Subject is ≥ 18 years of age.
3. Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.

Exclusion Criteria

1. Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
2. Subject is < 18 years of age.
3. Subject or Subject's LAR did not sign IRB-approved informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration	Hospital discharge

Trial Locations

Locations (2)

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States