The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Blood loss (mL / cm² excised)
研究概览
简要总结
Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.
Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).
Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.
详细描述
The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.
Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects undergoing burn excision surgery for standard of care purposes
- •Male or female >= 18 years of age
- •Subject or subject's medical decision maker agrees to participate in this study and provides informed consent
排除标准
- •Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
- •Renal impairment
- •Subjects with known hypersensitivity to tranexamic acid
- •Consecutive fibrinolytic states to coagulopathy
- •History of convulsions
研究组 & 干预措施
Tranexamic Acid
Patient will receive:
- 1g of tranexamic acid by slow intravenous injection
- 1g of tranexamic acid by syringe pump during 8 hours
干预措施: Tranexamic Acid (Drug)
Placebo
Patient will receive:
- 10 mL of 0.9% sodium chloride by slow intravenous injection
- 48 mL of 0.9% sodium chloride by syringe pump during 8 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Blood loss (mL / cm² excised)
时间窗: Until day 5 post surgery
To determine the impact of tranexamic acid on blood loss in burn surgeries
次要结局
- Deep vein thrombosis(Until day 15 post surgery)
- Stroke(Until day 15 post surgery)
- Pulmonary embolism(Until day 15 post surgery)
- Success of skin graft(Until day 15 post surgery)
- Myocardial infarction(Until day 15 post surgery)
- Need for transfusion(Until day 5 post surgery)
- All-cause Hospital Mortality(Until day 15 post surgery)
- Convulsion(Until day 15 post surgery)