Blood Transfusions and Immune Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-05-31

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Infection After Transfusion Transfusion-related Immunomodulation Reaction Cytokine Storm Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

restrictive transfusion strategy

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

liberal transfusion strategy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No