Blood Transfusions and Immune Response

Study Overview
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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.

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

Conditions
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Infection After Transfusion, Transfusion-related Immunomodulation Reaction, Cytokine Storm, Surgery

Intervention / Treatment
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* Procedure: restrictive transfusion strategy
* Procedure: liberal transfusion strategy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: restrictive transfusion strategy<br>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. | Procedure: restrictive transfusion strategy<br>* 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.<br>|
| Active Comparator: liberal transfusion strategy<br>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. | Procedure: liberal transfusion strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |