Status:
COMPLETED
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.
Lead Sponsor:
University of Louisville
Conditions:
Pancreaticoduodenectomy
Pancreatectomy
Eligibility:
All Genders
18+ years
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
- Subject is ≥ 18 years of age.
- Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.
Exclusion
- Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Subject is \< 18 years of age.
- Subject or Subject's LAR did not sign IRB-approved informed consent form.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00708513
Start Date
December 1 2003
End Date
December 1 2009
Last Update
October 21 2013
Active Locations (2)
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1
Norton Healthcare
Louisville, Kentucky, United States, 40202
2
University of Louisville Hospital
Louisville, Kentucky, United States, 40202