NCT06091891招募中不适用
Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- intraoperative bleeding loss
研究概览
简要总结
This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing scoliosis surgery under the age of 18
排除标准
- •Patients with coagulation disorders
- •Patients at an increased risk of thrombosis
- •Patients with a history of epilepsy or brain surgery
- •Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid
- •Severe liver or kidney impairment
- •Other cases deemed inappropriate by the researcher
研究组 & 干预措施
Control
Active Comparator
干预措施: Tranexamic acid (Drug)
ROTEM-guided
Experimental
干预措施: Tranexamic acid infusion under ROTEM-guidance (Drug)
结局指标
主要结局
intraoperative bleeding loss
时间窗: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
total volume of blood loss during surgery determined by anesthesiologist
次要结局
- Other blood transfusion(during surgery (From induction of anesthesia to when the patient leaves the operating room.))
- IL-6(1 hours from the end of surgery)
- total tranexamic acid dose(during surgery (From induction of anesthesia to when the patient leaves the operating room.))
- postoperative complications(2 weeks from the end of surgery)
- urine output(during surgery (From induction of anesthesia to when the patient leaves the operating room.))
- RBC blood transfusion(during surgery (From induction of anesthesia to when the patient leaves the operating room.))
- postoperative viscoelastic whole blood profile(1 hours from the end of surgery)
- JP drain(24 hours from the end of surgery)
研究者
Eun-hee Kim
clinical associate professor
Seoul National University Hospital
研究点 (1)
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