Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gentamicin serum concentration
研究概览
简要总结
Considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed. Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration of tranexamic acid.
The serum concentration of aminoglycosides has been measured in two groups of 20 patients each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and calculated blood loss were compared at several time points between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department
排除标准
- •patients who had been treated with gentamicin within the past 10 days
- •known allergies against the bone cement
- •estimated glomerular filtration rate (eGFR) <30ml/minute
- •previous nephrectomy and history of renal transplant
- •contraindications against tranexamic acid
研究组 & 干预措施
Self-transfusion group
Patients to whom a self-transfusion device has been used after total knee arthroplasty.
干预措施: Self-transfusion device (Device)
Control group
Patients to whom conventional drains have been used after total knee arthroplasty.
结局指标
主要结局
Gentamicin serum concentration
时间窗: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.
using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer
次要结局
未报告次要终点
研究者
Panagiotis Touzopoulos
Consultant of Orthopaedic Surgery
University Hospital, Alexandroupolis
