Clinical trial NCT02020525: Blood Transfusions and Immune Response
Official title: The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection After Transfusion
Transfusion-related Immunomodulation Reaction
Cytokine Storm
Surgery
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
timeFrame: first five postoperative days
Secondary outcomes:
measure: time of initial mobilization postoperatively
timeFrame: first five postoperative days
measure: time of first liquid food intake
timeFrame: first five postoperative days
measure: time of first solid food intake
timeFrame: first five postoperative days
measure: incidence of postoperative infectious complications
timeFrame: first five postoperative days
Other outcomes:
measure: 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
timeFrame: preoperatively, six, 24 and 72 hours postoperatively
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DEAA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.