Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative blood loss
研究概览
简要总结
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies
详细描述
40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass
排除标准
- •Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
研究组 & 干预措施
Group 3
the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
干预措施: topical tranexamic acid (Drug)
Group 1
In control group will receive normal saline,
干预措施: Normal saline at induction (Drug)
Group 1
In control group will receive normal saline,
干预措施: Normal saline infusion (Drug)
Group 1
In control group will receive normal saline,
干预措施: topical normal saline (Drug)
Group 2
Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
干预措施: Intravenous tranexamic acid (Drug)
Group 2
Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
干预措施: infusion tranexamic acid (Drug)
Group 2
Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
干预措施: topical normal saline (Drug)
Group 3
the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
干预措施: Normal saline at induction (Drug)
Group 3
the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
干预措施: Normal saline infusion (Drug)
结局指标
主要结局
postoperative blood loss
时间窗: within the first 24 hours
Blood loss will be measured within first 24 hr.
次要结局
- the interval from protamine to skin closure(within the first 24 hours)
- total blood transfusion(within the first 24 hours)
- the length of ICU stay(within the first month)
研究者
Sayed Kaoud Abd-Elshafy
Associate Profossor of Anesthesiology
Assiut University