A Randomised Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of Intramuscular, Intravenous and Oral Administration of Tranexamic Acid in Women Giving Birth by Caesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pharmacokinetic
研究概览
简要总结
Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)
详细描述
An open label, randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral solution administration of tranexamic acid in women giving birth by caesarean section. 120 women (30 receiving oral liquid, 30 receiving intramuscular, 30 receiving intravenous and 30 receiving no TXA who have at least 6 evaluable PK samples will be randomised.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women admitted to hospital giving birth by CS
- •History of at least one risk factor for PPH
- •Adult (≥18 years old)
排除标准
- •Women giving birth vaginally
- •Women with a known allergy to TXA or its excipients
- •Women with current antepartum haemorrhage
- •Women known to have received TXA within 48 hours prior to randomisation
- •Women with known renal impairment
- •Women with any known blood clotting disorder
研究组 & 干预措施
Intramuscular tranexamic acid
干预措施: Tranexamic Acid Injectable Product (Drug)
Intravenous tranexamic acid
干预措施: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml (Drug)
Oral liquid tranexamic acid
干预措施: Tranexamic Acid Oral Solution (Drug)
结局指标
主要结局
Pharmacokinetic
时间窗: 24 hours after randomisation
Concentration of TXA in Maternal blood over time
次要结局
- Number of women with a clinical diagnosis of PPH(up to 24 hours after giving birth)
- Concentration of D-dimer(up to 24 hours after randomisation)
- Maternal blood volume lost(from incision to 2 hours from CS)
- frequency of Injection site reaction from IM administration(from randomisation up to 7 days after)
- Placenta transfer of TXA(within 24 hours of birth)
- Number of Adverse events (maternal and neonate)(from randomisation up to 7 days after)