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Status unknownNCT02069210Updated Feb 24, 2014

The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

An observational study in Infection After Transfusion, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-02-24.

Sponsored by Mahidol University · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Infection After Transfusion
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients underwent elective spine surgery

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Blood transfusion

    Patients receive blood transfusion during operation

    Other: Blood transfusion

Interventions

  • OtherBlood transfusion

    Intraoperative blood transfusion

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02069210
Lead sponsor
Mahidol University
Collaborators
Wolf-Schleinzer-Stiftung
Responsible party
Sirilak Suksompong (Associated Professor, Mahidol University) — Principal investigator
First posted
Feb 24, 2014
Start date
May 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Feb 24, 2014

Study contacts

Sirilak Suksompong, MD
Contact
sirilak.suk@mahidol.ac.th
66891534806
Sirilak Suksompong, MD
study director · Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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