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Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations. (Cellsaver)
This study is currently recruiting participants.
Study NCT00708513   Information provided by University of Louisville
First Received: June 27, 2008   Last Updated: July 1, 2008   History of Changes

June 27, 2008
July 1, 2008
December 2003
March 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00708513 on ClinicalTrials.gov Archive Site
 
 
 
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.
Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations

The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

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.

 
Observational
Case-Only, Prospective
  • Pancreaticoduodenectomy
  • Pancreatectomy
  • Esophagectomy
  • Gastrectomy
  • Hepatectomy
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
90
December 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu
United States
 
NCT00708513
Robert C. G. Martin, University of Louisville
Cell Saver 704.03
University of Louisville
 
Principal Investigator: Robert CG Martin, MD University of Louisville
University of Louisville
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP