Cytokine Storm, Infection After Transfusion, Surgery, Transfusion-related Immunomodulation Reaction
Conditions
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.
Interventions
PROCEDURErestrictive 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.
PROCEDUREliberal 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.
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Secondary post-hoc analysis performed on a subgroup of 20 patients from the original study in order to determine whether there are any differences in the postoperative immunologic response between the two transfusion allocation groups | preoperatively, six, 24 and 72 hours postoperatively |
Countries
Greece
Outcome results
None listed