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Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations


N/A
18 Years
N/A
Not Enrolling
Both
Pancreaticoduodenectomy, Pancreatectomy, Esophagectomy, Gastrectomy, Hepatectomy

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Trial Information

Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Robert CG Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville

Authority:

United States: Institutional Review Board

Study ID:

Cell Saver 704.03

NCT ID:

NCT00708513

Start Date:

December 2003

Completion Date:

December 2009

Related Keywords:

  • Pancreaticoduodenectomy
  • Pancreatectomy
  • Esophagectomy
  • Gastrectomy
  • Hepatectomy
  • Cell Saver
  • Liver Tumors
  • Liver Cancer
  • Surgical Oncology
  • Whipple
  • Blood Transfusion
  • Blood salvage
  • cancer surgery
  • blood loss
  • blood transfusion

Name

Location

University of Louisville HospitalLouisville, Kentucky  40202
Norton HealthcareLouisville, Kentucky  40202