NCT02860221Unknown不适用
Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Total blood loss on the post-operative day 1
研究概览
简要总结
The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total knee arthroplasty.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the ages of 20 and 75 who were diagnosed with osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and those who were willing and able to return for follow-up over at least a 6-month postoperative period
排除标准
- •Acute coronary syndrome < 6 months
- •Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium < 3.0 mmol, alcohol abuse, premenopausal women
- •Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase(MAO) or Catechol-O-methyltransferase (COMT) inhibitors
- •Patients with history of thromboembolic disease, bleeding disorder
- •Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
- •Allergy to TXA
研究组 & 干预措施
Intravenous epinephrine
Experimental
Intravenous (IV) low dose epinephrine
干预措施: Tranexamic acid (TXA) (Drug)
Intravenous epinephrine
Experimental
Intravenous (IV) low dose epinephrine
干预措施: Epinephrine (Drug)
Topical epinephrine
Experimental
Topical epinephrine
干预措施: Tranexamic acid (TXA) (Drug)
Topical epinephrine
Experimental
Topical epinephrine
干预措施: Epinephrine (Drug)
Control
Active Comparator
No epinephrine
干预措施: Tranexamic acid (TXA) (Drug)
结局指标
主要结局
Total blood loss on the post-operative day 1
时间窗: 1 day post-operation
次要结局
- Post-operation Hospital for special surgery score (HSS)(3 months)
- Hematocrit (Hct)(7 day)
- Blood platelet count (PLT)(7 day)
- Haemoglobin (Hb)(7 day)
- Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)(Through study completion, an average of 3 months)
- Length of hospital stay (days)(3 months)
- Number of patients with infection(3 months)
- Number of deep vein thrombosis (DVT) cases(1 month)
- Number of pulmonary embolism (PE) cases(1 month)
- Intraoperative blood loss(3 hours)
- Total blood loss on the post-operative day 3(3 day post-operation)
- Reaction time (R-time)(24 hours)
- Rate of thrombus formation (K time)(24 hours)
- Maximum amplitude (MA)(24 hours)
- Rate of thrombus formation (α-angle)(24 hours)
- Lysis rate at 30 min (LY30)(24 hours)
- Coagulation index (CI)(24 hours)
- Intravenous fluid administration on the operation day(1 day)
- Interleukin(IL)-1β(24 hours)
- Interleukin(IL)-6(24 hours)
- Interleukin(IL)-8(24 hours)
- Tumor necrosis factor (TNF)-α(24 hours)
- C-reactive protein (CRP)(24 hours)
- Interleukin(IL)-10(24 hours)
- Wound score(14 day)
- Blood transfusion rate(7 day)
- Blood transfusion volume (mL)(7 day)
研究者
Liu Yang
Professor
Southwest Hospital, China
研究点 (1)
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