Cellsaver: Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT00708513

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy Pancreatectomy Esophagectomy Gastrectomy Hepatectomy

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 Design

Study Type:

Observational

Actual Enrollment :

98 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration [Hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.