2024-516324-34-01招募中4 期
Reduction of blood loss in pediatric osteotomies around the hip - A randomized placebo-controlled trial with tranexamic acid
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年11月21日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Estimated intraoperative blood loss (ml/kg)
研究概览
简要总结
To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a proximal femoral and/or pelvic osteotomy (PFPO).
Primary research question: Is pre-operative TXA administration associated with reduced intraoperative blood loss, compared to placebo, in children undergoing a proximal femoral and/or pelvic osteotomy for DDH or other indications?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Data collection and analysis
- 盲法
- Double (Carer, Investigator, Analyst, Monitor, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Proximal femoral and/or pelvic osteotomy/ies
- •1-18 years old
- •Any indication for surgery
- •Performed at our institution
排除标准
- •Contraindications for TXA
- •Active use of alternative (anti)fibrinolytics
- •Diagnosed bleeding or coagulation disorder
- •Medical history of thromboembolic complications
- •Use of hormonal contraception
- •Insufficient Dutch language skills of the patient and/or caretakers
- •No informed consent
结局指标
主要结局
Estimated intraoperative blood loss (ml/kg)
Estimated intraoperative blood loss (ml/kg)
次要结局
- Baseline demographic data
- Indication for surgery
- Prior surgery at same site
- Treatment characteristics
- Operative time
- Eventual additional antifibrinolytic agents administered during surgery (including TXA)
- Blood transfusions
- Pre- and postoperative blood values, including Hb
- Complications
- Duration of hospital stay
研究者
J.J. Tolk
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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