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| Sponsor: | University of Louisville |
|---|---|
| Information provided by: | University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00708513 |
Purpose
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 |
|---|
|
Pancreaticoduodenectomy Pancreatectomy Esophagectomy Gastrectomy Hepatectomy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2003 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 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.
Eligibility| 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:
Contacts and Locations| United States, Kentucky | |
| Norton Healthcare | |
| Louisville, Kentucky, United States, 40202 | |
| University of Louisville Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | Robert CG Martin, MD | University of Louisville |
More Information
| Responsible Party: | Robert C. G. Martin, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00708513 History of Changes |
| Other Study ID Numbers: | Cell Saver 704.03 |
| Study First Received: | June 27, 2008 |
| Last Updated: | January 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Cell Saver Liver Tumors Liver Cancer Surgical Oncology Whipple |
Blood Transfusion Blood salvage cancer surgery blood loss blood transfusion |