Blood Transfusions and Immune Response

Aretaieion University Hospital

Status: Completed

Conditions: Surgery; Cytokine Storm; Infection After Transfusion; Transfusion-related Immunomodulation Reaction

Treatments: Procedure: restrictive transfusion strategy; Procedure: liberal transfusion strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02020525

TRANSF-CYTOK

Details and patient eligibility

About

• 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

restrictive transfusion strategy

Experimental group

Description:

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.

Treatment:

Procedure: restrictive transfusion strategy

liberal transfusion strategy

Active Comparator group

Description:

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.

Treatment:

Procedure: liberal transfusion strategy