Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study
试验速览
- 阶段
- 4 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- volume of intraoperative blood loss
研究概览
简要总结
In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH.
The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. To prove the benefit of TXA for an attenuation of blood loss in brain tumor patients, research with a larger sample size is required. This prospective, randomized double-blind controlled study will be conducted to evaluate the effect of TXA in reducing blood loss and blood transfusion in patients with intracranial meningiomas, diameter > 5 cm in at least 2 dimensions from the latest radiographic findings.
详细描述
Background and Literature review:
- Meningioma
- Coagulation in craniotomy to remove meningioma
- Bleeding in craniotomy to remove meningioma
- Tranexamic acid (TXA)
- Knowledge gap The topics shown above has been reviewed to conduct a prospective randomized double-blind, placebo controlled study.
To prove the study hypothesis: Will intraoperative TXA administration in adult patients scheduled for craniotomy to remove large meningioma decrease blood loss?
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patients and outcome assessors are blinded to the drug that will be prepared by a pharmacist in the similar unlabelled 50-ml syringe.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients whose aged 18 to 60 years
- •The patients who was diagnosed intracranial meningioma
- •The radio-graphic finding of tumor diameter > 5 cm in at least 2 dimensions
- •The patients have written informed consent
- •The patients is scheduled for elective craniotomy to remove tumor
排除标准
- •Patients who refuse to participate in this study
- •Patients with recurrent tumor
- •The patient is set operation for intracranial tissue biopsy
- •The patients with history of TXA allergy
- •The pregnant patients
- •The patients with history of significant thromboembolic episode
- •The patients with significant renal dysfunction (GFR ≤ 50 ml/min)
研究组 & 干预措施
Experiment group
Each ampule contains TXA 250 mg. TXA preparation is 2000 mg dilute in normal saline 50 ml to get the concentration of 40 mg/ml. TXA will be administered 20 mg/kg loading over 20 min before skin incision followed by a maintenance infusion of 0.025 ml/kg/h (1 mg/kg/h) until the end of operation.
干预措施: Tranexamic acid (Drug)
Control group
Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
干预措施: Placebo (Drug)
结局指标
主要结局
volume of intraoperative blood loss
时间窗: in operating room during surgery
1. volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field 2. the blood from the dry (30 ml) and wet swab (50 ml) 3. serial Hgb / Hct periodically during surgery and compare to those obtain before surgery
次要结局
- the length of neuro-ICU stays(number of day remained intubation within 1 week after surgery)
- volume of blood being transfused(during surgery and 24 hour after surgery)
- surgeon rated for the satisfaction on hemostatic scale(in 2 hours after finish the operation)
- postoperative complications(in ICU neuro in 24 hours)
- the duration of postoperative ventilator use(number of day remained intubation within 1 week after surgery)
- the extent of tumor removal according to the surgeon decision(in 2 hours after finish the operation)
研究者
Pathomporn Pin on, M.D.
Assistant Professor
Chiang Mai University