ChiCTR-INR-17010965
Active, not recruiting
治疗新技术临床试验
加速康复模式下氨甲环酸不同应用方式对全膝关节置换术患者的临床效果评价
卫生部行业科研专项基金1 site in 1 country180 target enrollmentStarted: March 1, 2016Last updated:
Overview
- Phase
- 治疗新技术临床试验
- Status
- Active, not recruiting
- Sponsor
- 卫生部行业科研专项基金
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- 血色素水平
Overview
Brief Summary
全膝关节置换术后出血的重要原因是止血带效应所导致的纤溶亢进，通过使用抗纤溶药物--氨甲环酸减少围术期出血量越来越受到重视。本临床试验通过随机对照研究的方式，探讨静脉、口服、局部使用氨甲环酸对减少全膝关节置换术失血量的有效性和安全性。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Ages
- 20 to 80 (—)
- Sex
- All
Inclusion Criteria
- •研究期内在我院接受初次全膝关节置换手术的所有患者
Exclusion Criteria
- •氨甲环酸过敏的患者；术前肝肾功能障碍的患者；既往 7 天内有抗凝药物使用史的患者；既往诊断为纤溶异常或患有血液方面疾病患者；有脑血管意外、心肌梗死、纽约心脏协会心衰分级为 III 到 IV 级、心房颤动、深静脉血栓或肺栓塞、INR＞1.4、活化部分凝血酶原时间＞正常值 1.4 倍、血小板计数＜140000/mm3 等病史的患者。
Arms & Interventions
A
口服氨甲环酸
B
静脉氨甲环酸
C
局部氨甲环酸
Outcomes
Primary Outcomes
血色素水平
Secondary Outcomes
- 膝关节功能评价
- 围术期并发症：深静脉血栓和肺栓塞
- 住院费用
- 失血量（显性；隐性）
- Hct
- 输血
- 血沉，C 反应蛋白，白介素 6
- 疼痛
- D 二聚体
- 纤维蛋白降解产物
- 肢体肿胀比例
- 不良事件发生率
- 血栓弹力图
- 引流量
Investigators
Study Sites (1)
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