The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery

Aretaieion University Hospital1 site in 1 country58 target enrollmentDecember 2004

ConditionsInfection After Transfusion Transfusion-related Immunomodulation Reaction Cytokine Storm Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infection After Transfusion
Sponsor: Aretaieion University Hospital
Enrollment: 58
Locations: 1
Primary Endpoint: The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

May 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aretaieion University Hospital

Responsible Party

Principal Investigator

Dr Kassiani Theodoraki

Associate Professor in Anesthesiology

Aretaieion University Hospital

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

Outcomes

Primary Outcomes

The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)

Time Frame: first five postoperative days

Secondary Outcomes

time of initial mobilization postoperatively(first five postoperative days)
time of first liquid food intake(first five postoperative days)
time of first solid food intake(first five postoperative days)
incidence of postoperative infectious complications(first five postoperative days)