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CompletedNCT00708513CellsaverUpdated Oct 21, 2013

Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

An observational study in Pancreaticoduodenectomy, Pancreatectomy and Esophagectomy, sponsored by University of Louisville. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-21.

Sponsored by University of Louisville · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreaticoduodenectomy
  • Pancreatectomy
  • Esophagectomy
  • Gastrectomy
  • Hepatectomy

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Keywords

  • Cell Saver
  • Liver Tumors
  • Liver Cancer
  • Surgical Oncology
  • Whipple
  • Blood Transfusion
  • Blood salvage
  • cancer surgery
  • blood loss
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 98 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgical Oncology Clinic

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
98 participants (actual)
06

What researchers measure

Primary outcomes

  1. Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration

    Time frame: Hospital discharge

07

Study locations

2 sites
  • Norton Healthcare
    Louisville, Kentucky 40202, United States
  • University of Louisville Hospital
    Louisville, Kentucky 40202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00708513
Lead sponsor
University of Louisville
Responsible party
Robert C. Martin (MD, University of Louisville) — Principal investigator
First posted
Jul 2, 2008
Start date
Dec 2003
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Oct 21, 2013

Study contacts

Robert CG Martin, MD
principal investigator · University of Louisville

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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