NCT02864095Unknown不适用
The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 200 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
- 200
- 试验地点
- 1
- 主要终点
- Blood loss on 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 hip 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
- 18 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 as having osteoarthritis or osteonecrosis of the femoral head
- •Scheduled for an elective primary total hip arthroplasty
- •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
Blood loss on post-operative day 1
时间窗: 1 day
次要结局
- Serum levels of IL-10（Preoperation, intraoperation and post-operation）(Preoperation, intraoperation and up to 2 days post-operation)
- Number of plexus venosus leg muscle thrombosis(1 months)
- Serum levels of IL-1β（Preoperation, intraoperation and post-operation）(Preoperation, intraoperation and up to 2 days post-operation)
- Serum levels of TNF-α（Preoperation, intraoperation and post-operation）(Preoperation, intraoperation and up to 2 days post-operation)
- Blood loss on post-operative day 3(3 days)
- Number of pulmonary embolism cases(1 months)
- Serum levels of IL-6（Preoperation, intraoperation and post-operation）(Preoperation, intraoperation and up to 2 days post-operation)
- Preoperation, intraoperation and post-operation K value (min) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Length of hospital stay(1 months)
- Number of patients with infection(1 months)
- Number of deep vein thrombosis cases(1 months)
- Haemoglobin (Hb)(7 days)
- Hematocrit (Hct)(7 days)
- Preoperation, intraoperation and post-operation R value (min) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Platelets (PLT)(7 days)
- Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram(Preoperation, intraoperation and up to 2 days post-operation)
- Number of patients with blood transfusion(7 days)
研究者
Liu Yang
Professor
Southwest Hospital, China
研究点 (1)
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