ChiCTR-ORC-16009358
Completed
回顾性研究
氨甲环酸的不同用法在初次单侧全膝关节表面置换术中的作用
国家卫生和计划生育委员会1 site in 1 country560 target enrollmentStarted: June 26, 2013Last updated:
Overview
- Phase
- 回顾性研究
- Status
- Completed
- Sponsor
- 国家卫生和计划生育委员会
- Enrollment
- 560
- Locations
- 1
- Primary Endpoint
- Haemoglobin loss
Overview
Brief Summary
目前，暂未有一项研究同时评估氨甲环酸哪种给药途径在降低术后失血量、输血量、额外费用和副作用比如（血栓栓塞的并发症等）方面是最好的。因此，该研究的目的是针对要进行初次单侧全膝表面置换术的患者，同时评估静脉给药、关节局部用药和口服给药中哪种途径对患者最有利。
Study Design
- Study Type
- 观察性研究
- Primary Purpose
- 队列研究
Eligibility Criteria
- Ages
- 47 to 84 (—)
- Sex
- All
Inclusion Criteria
- •膝关节骨关节炎或类风湿性关节炎的患者；初次进行单侧膝关节表面置换术的患者；至少达到 3 周的随访时间；凝血机制正常；内科疾病（比如糖尿病、高血压等）在术前得到有效控制。
Exclusion Criteria
- •要求一次进行双侧膝关节表面置换术的患者；膝关节翻修的患者；患有严重的肝肾、心血管和肺部疾病的患者；凝血性和出血性疾病；以及近期接受抗凝治疗的患者。
Arms & Interventions
intravenous group
The intravenous group received 20mg/kg of TXA administered intravenously 30 minutes before incising skin and the same dose and administration 12 hours postoperatively.
topical group
The topical group received 3.0g TXA (total 60ml solution) administered intra-articularly after subcutaneous tissue was sutured.
oral group
The oral group received 20mg/kg of TXA administered orally 2 hours preoperatively and the same dose and administration 12 hours postoperatively.
blank group
No TXA was used for the blank group.
Outcomes
Primary Outcomes
Haemoglobin loss
Time Frame: 48 hours postoperatively
Drainage volume
Time Frame: 48 hours postoperatively
Transfusion units
Additional cost
Secondary Outcomes
- Tourniquet time
- Thromboembolic complications
- Wound healing
Investigators
Study Sites (1)
Loading locations...
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陈旺医师：请完善注册表测量指标的填写；请于伦理委员会批准后才开始征募参试者，并与我们联系上传伦理批件；请上传研究计划书、知情同意书模板。 全膝关节置换术疗效和安全性的局部氨甲环酸的最佳剂量：一项随机对照研究ChiCTR2000038219无240