Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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

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Pancreaticoduodenectomy Pancreatectomy Esophagectomy Gastrectomy Hepatectomy

Keywords

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Cell Saver Liver Tumors Liver Cancer Surgical Oncology Whipple Blood Transfusion Blood salvage cancer surgery blood loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Robert C. Martin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert CG Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Norton Healthcare

Louisville, Kentucky, United States

Site Status

University of Louisville Hospital