Blood Transfusions and Immune Response

Not Applicable

Completed

• Conditions: Transfusion-related Immunomodulation Reaction; Cytokine Storm; Surgery; Infection After Transfusion
• Interventions: Procedure: liberal transfusion strategy; Procedure: restrictive transfusion strategy

• Registration Number: NCT02020525
• Lead Sponsor: Aretaieion University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liberal transfusion strategy	liberal transfusion strategy	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.
restrictive transfusion strategy	restrictive transfusion strategy	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.

Primary Outcome Measures

Name	Time	Method
The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)	first five postoperative days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aretaieion University Hospital; 🇬🇷 Athens, Greece