Blood Transfusions and Immune Response

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020525
• Other study ID #: TRANSF-CYTOK
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: May 2007

Study information

• Verified date: February 2019
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & 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. — View 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. Review. — View Citation

Hébert 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. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056. — View 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. — View Citation

Leal Noval SR, Jara López 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. — View 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. — View 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 — View Citation

Vamvakas EC, Blajchman MA. Deleterious clinical effects of transfusion-associated immunomodulation: fact or fiction? Blood. 2001 Mar 1;97(5):1180-95. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	time of initial mobilization postoperatively		first five postoperative days
Secondary	time of first liquid food intake		first five postoperative days
Secondary	time of first solid food intake		first five postoperative days
Secondary	incidence of postoperative infectious complications		first five postoperative days