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Blood Transfusions and Immune Response

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ClinicalTrials.gov Identifier: NCT02020525
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

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.

Condition or disease Intervention/treatment Phase
Infection After Transfusion Transfusion-related Immunomodulation Reaction Cytokine Storm Surgery Procedure: restrictive transfusion strategy Procedure: liberal transfusion strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020525


Locations
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Greece
Aretaieion University Hospital
Athens, Greece, 115 28
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DEAA Aretaieion University Hospital
Publications of Results:
Other Publications:
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Responsible Party: Dr Kassiani Theodoraki, Associate Professor in Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT02020525    
Other Study ID Numbers: TRANSF-CYTOK
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019