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| Descriptive Information Fields | |||||
| Brief Title † | Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations. | ||||
| Official Title † | Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Pancreaticoduodenectomy Pancreatectomy Esophagectomy Gastrectomy Hepatectomy |
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| Intervention † | |||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 90 | ||||
| Start Date † | December 2003 | ||||
| Completion Date | December 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00708513 | ||||
| Organization ID | Cell Saver 704.03 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Louisville | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of Louisville | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | June 27, 2008 | ||||
| Last Updated Date | July 1, 2008 | ||||