Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- blood loss 24 hours (ml)
研究概览
简要总结
The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.
PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.
Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.
Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.
Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.
STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or more
- •ASA I-III
- •No allergies tranexamic acid
- •Informed consent signed by patient
排除标准
- •Pregnancy or lactation.
- •severe vascular ischemia (coronary or peripheral)
- •previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)
- •coagulopathy
- •Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension
- •Hemoglobine <10
- •moderate renal impairment (creatinine> 2)
- •Cirrhosis
- •contraindication to prophylaxis with enoxaparin
- •Patients with a history of seizures.
研究组 & 干预措施
A
Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.
干预措施: A (Drug)
B
Group B: 1st dose: 10mg/kg of TXA (tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.
干预措施: B (Drug)
C
Placebo
干预措施: C (Drug)
结局指标
主要结局
blood loss 24 hours (ml)
时间窗: 24 hours
blood loss (ml)
时间窗: 4 hours
blood loss 8 hours (ml)
时间窗: 8 hours
次要结局
未报告次要终点