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

This study is currently recruiting participants.
Verified by University of Louisville, May 2008

Sponsored by: 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

MedlinePlus related topics:   Blood Transfusion and Donation   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations

Further study details as provided by University of Louisville:

Biospecimen Retention:   None Retained

Biospecimen Description:

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)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Surgical Oncology Clinic


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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708513

Contacts
Contact: Susan Ellis, RN     502-629-3384     susan.ellis@louisville.edu    

Locations
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            

Sponsors and Collaborators
University of Louisville

Investigators
Principal Investigator:     Robert CG Martin, MD     University of Louisville    
  More Information


Responsible Party:   University of Louisville ( Robert C. G. Martin )
Study ID Numbers:   Cell Saver 704.03
First Received:   June 27, 2008
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00708513
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Louisville:
Cell Saver  
Liver Tumors  
Liver Cancer  
Surgical Oncology  
Whipple  
Cell Saver  
Blood Transfusion
Blood salvage
cancer surgery
blood loss
blood transfusion

Study placed in the following topic categories:
Liver Neoplasms
Liver neoplasms
Hemorrhage
Hepatocellular carcinoma

ClinicalTrials.gov processed this record on October 10, 2008




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