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临床试验/NCT04505748
NCT04505748已完成不适用

Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial

University Hospital, Alexandroupolis1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

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

Experimental

Patients to whom a self-transfusion device has been used after total knee arthroplasty.

干预措施: Self-transfusion device (Device)

Control group

No Intervention

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

发起方
University Hospital, Alexandroupolis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiotis Touzopoulos

Consultant of Orthopaedic Surgery

University Hospital, Alexandroupolis

研究点 (1)

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