Unknown statusInterventionalPhase 3Updated Nov 30, 2009
Blood Transfusions and Immune Response | NCT02020525 | Trialant
CompletedInterventionalNot ApplicableUpdated Feb 15, 2019
Blood Transfusions and Immune Response
The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
ClinicalTrials.gov ID
NCT02020525
Lead Sponsor
Aretaieion University HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
58Actual
Last Update Posted
Feb 15, 2019Actual
Start Date
Dec 2004
Primary Completion Date
May 2007Actual
Completion Date
May 2007Actual
Official Title
The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
Brief Summary
We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery.
The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied.
The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.
Infection After Transfusion
Transfusion-related Immunomodulation Reaction
Cytokine Storm
Surgery
restrictive transfusion strategy
liberal transfusion strategy
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery
Exclusion Criteria:
history of bleeding diathesis
hereditary hemostatic defects such as hemophilias
chronic anticoagulant administration
refusal of transfusions for religious reasons
ischemic heart disease (unstable angina or myocardial infarction within the last six months)
preexisting infectious diseases
preexisting autoimmune diseases
use of corticosteroids or immunosuppressive drugs within the last six months