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Blood Transfusions and Immune Response

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
restrictive transfusion strategy
liberal transfusion strategy
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infection After Transfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aretaieion University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

restrictive transfusion strategy

liberal transfusion strategy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time of initial mobilization postoperatively
time of first liquid food intake
time of first solid food intake
incidence of postoperative infectious complications

Full Information

First Posted
December 18, 2013
Last Updated
February 14, 2019
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02020525
Brief Title
Blood Transfusions and Immune Response
Official Title
The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection After Transfusion, Transfusion-related Immunomodulation Reaction, Cytokine Storm, Surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
restrictive transfusion strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
liberal transfusion strategy
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
restrictive transfusion strategy
Intervention Description
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
Intervention Name(s)
liberal transfusion strategy
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
time of initial mobilization postoperatively
Time Frame
first five postoperative days
Title
time of first liquid food intake
Time Frame
first five postoperative days
Title
time of first solid food intake
Time Frame
first five postoperative days
Title
incidence of postoperative infectious complications
Time Frame
first five postoperative days
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DEAA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
115 28
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
1393463
Citation
Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
Results Reference
background
PubMed Identifier
18354101
Citation
Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
Results Reference
background
PubMed Identifier
11222359
Citation
Vamvakas EC, Blajchman MA. Deleterious clinical effects of transfusion-associated immunomodulation: fact or fiction? Blood. 2001 Mar 1;97(5):1180-95. doi: 10.1182/blood.v97.5.1180. No abstract available.
Results Reference
background
PubMed Identifier
12199847
Citation
Leal Noval SR, Jara Lopez I. Do multiple blood transfusions predispose for a higher rate of non-blood-related infection complications? Clin Microbiol Infect. 2002 Jul;8(7):383-7. doi: 10.1046/j.1469-0691.2002.00465.x.
Results Reference
background
PubMed Identifier
9971864
Citation
Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601. Erratum In: N Engl J Med 1999 Apr 1;340(13):1056.
Results Reference
background
PubMed Identifier
8614042
Citation
Sherry RM, Cue JI, Goddard JK, Parramore JB, DiPiro JT. Interleukin-10 is associated with the development of sepsis in trauma patients. J Trauma. 1996 Apr;40(4):613-6; discussion 616-7. doi: 10.1097/00005373-199604000-00016.
Results Reference
background
PubMed Identifier
19138255
Citation
Bilgin YM, Brand A. Transfusion-related immunomodulation: a second hit in an inflammatory cascade? Vox Sang. 2008 Nov;95(4):261-71. doi: 10.1111/j.1423-0410.2008.01100.x.
Results Reference
background
PubMed Identifier
24804272
Citation
Theodoraki K, Markatou M, Rizos D, Fassoulaki A. The impact of two different transfusion strategies on patient immune response during major abdominal surgery: a preliminary report. J Immunol Res. 2014;2014:945829. doi: 10.1155/2014/945829. Epub 2014 Apr 3.
Results Reference
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Blood Transfusions and Immune Response

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