Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
研究概览
简要总结
Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery thrombosis (HAT) compared to low molecular weight heparin.
详细描述
In pediatric patients with post-transplant hepatic artery thrombosis (HAT) , low molecular weight heparin is a commonly used method. Ticagrelor, a direct-acting and reversible ADP receptor antagonist, is now the most commonly used ADP receptor antagonist in the treatment of coronary diseases. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. The present study is to evaluate the safety and efficacy of Ticagrelor in pediatirc receipt with post-operative HAT.
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
- None
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 2 months to 5 years old.
- •voluntary participation in clinical trials, and informed consent;
- •Contrast- Enhanced Ultrasonography proved HAT
排除标准
- •History of sensitivity to study medications or any of their excipients
- •Renal failure (eGFR <30 or requiring dialysis)
- •A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
- •Prior stroke
- •Active pathological bleeding
- •History of intracranial haemorrhage
- •Life expectancy <12 months based on investigator's judgement
- •Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular [AV)] block) unless already treated with a permanent pacemaker
- •Anemia (hematocrit < 27%)
- •Platelet count < 100,000/ml
- •Concomitant use of strong CYP 3A inhibitors or inducers
研究组 & 干预措施
Ticagrelor, 2-3mg/kg, 12h
2-3mg/kg, q12h, p.o. for 2w
干预措施: Ticagrelor Oral Tablet [Brilinta] (Drug)
low molecular weight heparin
half amount low molecular weight heparin
干预措施: Low molecular weight heparin (Drug)
结局指标
主要结局
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
时间窗: 3 months
The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)
次要结局
- High on-treatment platelet reactivity (HPR)(Two hours after the injection of either active drug or placebo)
- Post-operative major bleeding event(within 72 hours after operation)