Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mean intraoperative blood loss
研究概览
简要总结
Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.
详细描述
During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery.
This study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •either gender.
- •presenting within seven days of trauma.
- •planned for maxillofacial surgery.
排除标准
- •Patients with international normalized ratio (INR) greater than 1.
- •American Society of Anesthesiologists (ASA) physical status of 3 or higher.
- •chronic kidney disease.
研究组 & 干预措施
Trenexamic acid group
Thirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg.
干预措施: Tranexamic Acid (TXA) (Drug)
Placebo group
Thirty minutes prior to surgery, the placebo group received 20 mL of normal saline.
干预措施: Normal saline (Drug)
结局指标
主要结局
mean intraoperative blood loss
时间窗: Immediately at the end of surgery
mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery.
次要结局
- mean drop in hemoglobin levels postoperatively(03 hours after post operatively)
- intraoperative blood transfusion(Preoperative)
研究者
Shakir Hussain
Postgraduate resident Oral and maxillofacial surgery
Nishtar Medical University