The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients|
- 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.
- 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).
- 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.
- 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
|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)|
Patients receive blood transfusion during operation
Other: Blood transfusion
Intraoperative blood transfusion
Please refer to this study by its ClinicalTrials.gov identifier: NCT02069210
|Contact: Sirilak Suksompong, MDfirstname.lastname@example.org|
|Sirilak Suksompong||Not yet recruiting|
|Bangkok, Thailand, 10700|
|Contact: Sirilak Suksompong, MD 66891534806 email@example.com|
|Study Director:||Sirilak Suksompong, MD||Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University|