Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Hepatectomy Clinical Trial

— Cellsaver  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708513
• Other study ID #: Cell Saver 704.03
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: October 18, 2013
• Start date: December 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2013
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophagectomy
• Gastrectomy
• Hepatectomy
• Pancreatectomy
• Pancreaticoduodenectomy

Locations

Country	Name	City	State
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration		Hospital discharge	Yes