The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 24, 2014
February 1, 2014
1.6 years
February 17, 2014
February 19, 2014
Conditions
Outcome Measures
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.
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.
1 month
Study Arms (1)
Blood transfusion
Patients receive blood transfusion during operation
Interventions
Eligibility Criteria
Patients underwent elective spine surgery
You may qualify if:
- Age \> 18 - \< 60 years
- Patients underwent elective spine surgery
- ASA classification 1-3
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Wolf-Schleinzer-Stiftungcollaborator
Study Sites (1)
Sirilak Suksompong
Bangkok, 10700, Thailand
Biospecimen
Blood
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sirilak Suksompong, MD
Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 24, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 24, 2014
Record last verified: 2014-02