The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunologic parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 - < 60 years
- •Patients underwent elective spine surgery
- •ASA classification 1-3
排除标准
- •Patients who have the concomitant condition
- •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)
结局指标
主要结局
Immunologic parameters
时间窗: 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.
次要结局
- 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)
研究者
Sirilak Suksompong
Associated Professor
Mahidol University