The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Mahidol University
Sponsor:
Collaborator:
Wolf-Schleinzer-Stiftung
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier:
NCT02069210
First received: February 17, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Mahidol University:

Primary Outcome Measures:
  • Immunologic parameters [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Blood


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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sirilak Suksompong, Associated Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02069210     History of Changes
Other Study ID Numbers: SI 1
Study First Received: February 17, 2014
Last Updated: February 19, 2014
Health Authority: Thailand: Ethical Committee

ClinicalTrials.gov processed this record on September 30, 2014