The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Perioperative blood loss
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty.
Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration
详细描述
Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.
The study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing knee joint arthroplasty.
- •Saudi and Non-Saudi Patient.
- •Patients who have Complete medical record.
排除标准
- •End stage renal disease
- •Liver cirrhosis
- •Coagulopathy
- •Pre-operative Hgb <10
- •History of cerebrovascular accident or myocardial infarction in past 12 months.
- •History of Heart failure.
- •History of arrhythmia.
- •History of pheochromocytoma, thyrotoxicosis and glaucoma.
- •Pregnancy or breast feeding
- •History of Deep venous thrombosis or pulmonary embolism
- •Allergy to epinephrine or tranexamic acid
研究组 & 干预措施
Epinephrine + Tranexamic Acid Group
The experimental group will receive both epinephrine and tranexamic acid
干预措施: low-dose epinephrine and tranexamic acid (Drug)
Tranexamic Acid Group
The comparator group will receive only tranexamic acid
干预措施: Tranexamic Acid (TXA) treatment (Drug)
结局指标
主要结局
Perioperative blood loss
时间窗: Daily, till post-operative day 5
Calculated 24 h blood loss in mL, Hidden blood loss in mL, Hemoglobin levels in g/dL, Hematocrit levels as a percentage, Platelets count in cells/µL.
次要结局
- Thromboembolic complications(Daily, till post-operative day 5)
- Hospitalization duration(Daily, till post-operative day 5)
- Drug side effects (epinephrine + tranexamic acid)(Daily, till post-operative day 5)
- Complications(Daily, till post-operative day 5)
研究者
Wazzan Saleh ALJuhani
Principal investigator, Orthopedic Surgeon
King Abdullah International Medical Research Center