The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Overview

The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Interventions

  • Other: Blood transfusion
    • Intraoperative blood transfusion

Arms, Groups and Cohorts

  • Blood transfusion
    • Patients receive blood transfusion during operation

Clinical Trial Outcome Measures

Primary Measures

  • Immunologic parameters
    • Time Frame: 7 days
    • Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7. IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, Il-7, IL-8, Il-9, Il-10, Il-12, Il-13, IL-15, Il-17,basic FGF (Fibroblast growth factors). Cell Analytics – (mononuclear) T-Cells incl. killer cells, CD2, CD3, CD4, CD8, CD25, CD30, CD19, CD20, CD138, CD56, CD56, CD303, CD304, NK cytotoxicity (non-radioisotope), CTL cytotoxicity (non-radioisotope), T cell proliferation, B cell, T cell.

Secondary Measures

  • To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay.
    • Time Frame: 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 – < 60 years – Patients underwent elective spine surgery – ASA classification 1-3 Exclusion Criteria:

  • Patients who have the concomitant condition – Cancer – History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament. – Serum creatinine > 1.5 mg/dL – Stroke, neurologic and mental deficits, epilepsy – General or local infection (site of surgery), – Coagulation disorders. – Intraoperative massive bleeding – Infection of the spine – Rheumatoid arthritis – Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Collaborator
    • Wolf-Schleinzer-Stiftung
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sirilak Suksompong, Associated Professor – Mahidol University
  • Overall Official(s)
    • Sirilak Suksompong, MD, Study Director, Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
  • Overall Contact(s)
    • Sirilak Suksompong, MD, 66891534806, sirilak.suk@mahidol.ac.th

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.