Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.
详细描述
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
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, Investigator, Outcomes Assessor)
盲法说明
Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing ORIF under GA for Maxillofacial fractures
- •Patients between with ages of 16-65
- •No cardiac comorbidities (hypertension, congenital heart malformation)
- •No known coagulopathy
- •No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
- •ASA I and II patients
排除标准
- •Patients younger than 16 and older than 65
- •Patients with known coagulopathy
- •Patients with cardiac comorbidities
- •Patients with a family history of bleeding disorders
- •ASA III or higher
研究组 & 干预措施
Tranexamic acid
Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
干预措施: Tranexamic acid (Drug)
Placebo
Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
干预措施: Placebo (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: Surgical period
Measured and recorded from the anaesthesia patient chart
次要结局
- Postoperative bleeding event(upto 48 hours after surgery)
研究者
Ashutosh Kumar Singh
Associate professor
College of Medical Sciences Teaching Hospital. Nepal