The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069210

Enrollment

Registered

2014-02-24

Start date

2014-05-31

Completion date

2015-12-31

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection After Transfusion

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.

Interventions

OTHERBlood transfusion

Intraoperative blood transfusion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

Thailand

Contacts

Primary ContactSirilak Suksompong, MD

sirilak.suk@mahidol.ac.th66891534806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026