A study to assess the efficacy of intravenous tranexamic acid prior to burns surgery in a tertiary care centre
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Blood loss in ml
研究概览
简要总结
Blood loss during excisional surgery in burn patients remains a challenge and has been identified as an independent predictor of mortality
Limited interventions are available to decrease blood loss during burns surgery like use of topical adrenaline, topical tranexamic acid & tourniquet Despite the use of these techniques, blood loss during burn surgery is substantialThis leads to allogenic blood transfusions with all associated risks and costsTranexamic acid is a synthetic lysine analogue that competitively inhibits the activation of plasminogen, thereby inhibiting the degradation of fibrin Tranexamic acid has a proven efficacy in reducing blood loss in different patient categories
The study aims to identify if blood loss is decreased by use of intravenous tranexamic acid prior to burns surgery as blood loss is an important indicator of morbidity & mortality post burn surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All males and females aged 18-60 yrs All patients with less than 30% deep dermal (2nd degree and above) burns Patient willing to give informed consent.
排除标准
- •Patients with coagulopathy Pregnancy Patients with chronic kidney disease Patients with allergy to tranexamic acid Acute venous or arterial thrombosis within 3 months of inclusion in the study Seizure disorder.
结局指标
主要结局
Blood loss in ml
时间窗: blood loss assessed intra operatively | amount of blood transfusion required on post op day 1 | pre and post op hemoglobin and hematocrit on post op day 1
Amount of blood transfusion required
时间窗: blood loss assessed intra operatively | amount of blood transfusion required on post op day 1 | pre and post op hemoglobin and hematocrit on post op day 1
Pre and post op hemoglobin and hematocrit
时间窗: blood loss assessed intra operatively | amount of blood transfusion required on post op day 1 | pre and post op hemoglobin and hematocrit on post op day 1
次要结局
- Percentage of graft uptake(post op day5 7 and 14)
研究者
Dr PEDDI MANJUNATH
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE