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The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University Identifier:
First received: February 17, 2014
Last updated: February 19, 2014
Last verified: February 2014
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.

Condition Intervention
Infection After Transfusion Other: Blood transfusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Resource links provided by NLM:

Further study details as provided by Sirilak Suksompong, Mahidol University:

Primary Outcome Measures:
  • Immunologic parameters [ Time Frame: 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:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blood transfusion
Patients receive blood transfusion during operation
Other: Blood transfusion
Intraoperative blood transfusion


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02069210

Contact: Sirilak Suksompong, MD 66891534806

Sirilak Suksompong Not yet recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    66891534806   
Sponsors and Collaborators
Mahidol University
Study Director: Sirilak Suksompong, MD Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
  More Information

Responsible Party: Sirilak Suksompong, Associated Professor, Mahidol University Identifier: NCT02069210     History of Changes
Other Study ID Numbers: SI 1
Study First Received: February 17, 2014
Last Updated: February 19, 2014 processed this record on September 21, 2017