Blood Transfusions and Immune Response

NCT02020525 | Completed DMC

• 1 other identifier: TRANSF-CYTOK
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection After Transfusion; Transfusion-related Immunomodulation Reaction; Cytokine Storm; Surgery

Outcome Measures

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)

  first five postoperative days

Secondary Outcomes (4)

• 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 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

  preoperatively, six, 24 and 72 hours postoperatively

Study Arms (2)

restrictive transfusion strategy

EXPERIMENTAL

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

liberal transfusion strategy

ACTIVE COMPARATOR

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

Interventions

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.

restrictive transfusion strategy

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.

liberal transfusion strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

Location

Related Publications (8)

• 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.

  PMID: 1393463 BACKGROUND

• 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.

  PMID: 18354101 BACKGROUND

• 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.

  PMID: 11222359 BACKGROUND

• 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.

  PMID: 12199847 BACKGROUND

• 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.

  PMID: 9971864 BACKGROUND

• 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.

  PMID: 8614042 BACKGROUND

• 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.

  PMID: 19138255 BACKGROUND

• 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.

  PMID: 24804272 RESULT

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Kassiani Theodoraki, PhD, DEAA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 25, 2013
• Study Start: December 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

GR (1)