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NCT Number: NCT02020525

Blood Transfusions and Immune Response

* 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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Key information

Conditions

Infection After Transfusion Cytokine Release Syndrome Cytokine Storm Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Surgery Systemic Inflammatory Response Syndrome Transfusion-related Immunomodulation Reaction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, 115 28, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

restrictive transfusion strategy

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

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.

Primary outcomes

  1. The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)

    Time frame: first five postoperative days

Secondary outcomes

  1. time of initial mobilization postoperatively

    Time frame: first five postoperative days

  2. time of first liquid food intake

    Time frame: first five postoperative days

  3. time of first solid food intake

    Time frame: first five postoperative days

  4. incidence of postoperative infectious complications

    Time frame: first five postoperative days

Other outcomes

  1. 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

    Time frame: preoperatively, six, 24 and 72 hours postoperatively

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Dec 25, 2013
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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