Blood Transfusions and Immune Response

N/ACompletedNCT02020525

Aretaieion University Hospital58 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Infection After Transfusion Transfusion-related Immunomodulation Reaction Cytokine Storm

Interventions

restrictive transfusion strategyPROCEDURE

Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.

liberal transfusion strategyPROCEDURE

Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)