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The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

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ClinicalTrials.gov Identifier: NCT02069210
Recruitment Status : Unknown
Verified February 2014 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Sponsor:
Collaborator:
Wolf-Schleinzer-Stiftung
Information provided by (Responsible Party):
Sirilak Suksompong, 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.

Condition or disease Intervention/treatment
Infection After Transfusion Other: Blood transfusion

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Blood transfusion
Patients receive blood transfusion during operation
Other: Blood transfusion
Intraoperative blood transfusion




Primary Outcome Measures :
  1. 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 :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood


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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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069210


Contacts
Contact: Sirilak Suksompong, MD 66891534806 sirilak.suk@mahidol.ac.th

Locations
Thailand
Sirilak Suksompong Not yet recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    66891534806    sirilak.suk@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Wolf-Schleinzer-Stiftung
Investigators
Study Director: Sirilak Suksompong, MD Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University

Responsible Party: Sirilak Suksompong, Associated Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02069210     History of Changes
Other Study ID Numbers: SI 1
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014