The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

N/AUnknownNCT02069210

Mahidol University40 enrolled

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

OBSERVATIONAL

Enrollment

Conditions

Infection After Transfusion

Interventions

Blood transfusionOTHER

Intraoperative blood transfusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sirilak Suksompong

Bangkok, Thailand

Outcomes

Primary Outcomes

Immunologic parameters

Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7. 1. 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). 2. 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.

Time frame: 7 days

Secondary Outcomes

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

Central Contacts

Sirilak Suksompong, MD

CONTACT

66891534806 sirilak.suk@mahidol.ac.th

Data from ClinicalTrials.gov

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