The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

• Conditions: Infection After Transfusion
• Interventions: Other: Blood transfusion

• Registration Number: NCT02069210
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-24
• Last Update Posted: 2014-02-24
• Study Start: 2014-05
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood transfusion	Blood transfusion	Patients receive blood transfusion during operation

Primary Outcome Measures

Name	Time	Method
Immunologic parameters	7 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sirilak Suksompong; 🇹🇭 Bangkok, Thailand