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

This study is currently recruiting participants.
Study NCT00708513.   Last updated on July 1, 2008.   Information provided by University of Louisville

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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.

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 Phase
Study Type  Observational
Study Design  Case-Only, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Pancreaticoduodenectomy
Pancreatectomy
Esophagectomy
Gastrectomy
Hepatectomy
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  90
Start Date  December 2003
Completion Date December 2009
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Susan Ellis, RN     502-629-3384     susan.ellis@louisville.edu    
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 
Principal Investigator:     Robert CG Martin, MD     University of Louisville    
Information Provided By University of Louisville
Verification Date May 2008
First Received Date  June 27, 2008
Last Updated Date July 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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