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Sponsored by: |
University of Louisville |
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Information provided by: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00708513 |
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 |
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Pancreaticoduodenectomy Pancreatectomy Esophagectomy Gastrectomy Hepatectomy |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations |
Estimated Enrollment: | 90 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Surgical Oncology Clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan Ellis, RN | 502-629-3384 | susan.ellis@louisville.edu |
United States, Kentucky | |
Norton Healthcare | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu | |
Principal Investigator: Robert Martin, MD | |
University of Louisville Hospital | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu | |
Principal Investigator: Rob Martin, MD |
Principal Investigator: | Robert CG Martin, MD | University of Louisville |
Responsible Party: | University of Louisville ( Robert C. G. Martin ) |
Study ID Numbers: | Cell Saver 704.03 |
Study First Received: | June 27, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00708513 |
Health Authority: | United States: Institutional Review Board |
Cell Saver Liver Tumors Liver Cancer Surgical Oncology Whipple Cell Saver |
Blood Transfusion Blood salvage cancer surgery blood loss blood transfusion |
Liver Neoplasms Liver neoplasms Hemorrhage |