Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
研究概览
简要总结
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.
详细描述
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
- •All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
- •The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.
排除标准
- •Allergy to tranexamic acid;
- •Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
- •Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
- •Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
- •Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products;
- •Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).
研究组 & 干预措施
Experimental
Receiving TXA, Study group
Tranexamic acid, Study group tranexamic acid 1g,
intravenous injection, pre-operationally
干预措施: Glutamine (Drug)
Placebo Comparator
Normal saline, Control group
Not receiving tranexamic acid, Control group Normal
saline 100mL, intravenous injection, pre-operationally
干预措施: Normal saline (Drug)
结局指标
主要结局
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
时间窗: one week after surgery
次要结局
未报告次要终点
研究者
Yanzhao
Dr
Xijing Hospital