Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison in the amount of blood products transfused between the groups
研究概览
简要总结
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely International Normalised Ratio (INR) and Platelets count] are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in cirrhotic children undergoing invasive procedures.
详细描述
Children with cirrhosis listed for invasive procedures and with deranged INR or deranged platelet count will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR, platelet and fibrinogen.The second group will undergo ROTEM based correction.
Following correction, the procedure will be done in both the groups. Patients randomized in the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on the component transfused), post the procedure, to look at the correction achieved. Similarly, patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen testing depending on the component transfused.
Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion reaction.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedures : Low risk of bleeding
- •Central venous cannulation
- •Haemodialysis catheter
- •Ascitic or Pleural tapping
- •Endoscopic variceal ligation (EVL)
- •Endoscopic sclerotherapy (EST)
- •High risk of bleeding
- •Endoscopic retrograde cholangiopancreatography (ERCP) with sphicterotomy
- •Percutaneous drain (PCD) Insertion
- •Biopsies other than liver biopsy
- •For children less than 18 years with liver cirrhosis and with a platelet count between 40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for
- •Liver biopsy
排除标准
- •Anti platelet or anti coagulant therapy in the previous 7 days
- •Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
- •Hemodialysis in the past 7 days
结局指标
主要结局
Comparison in the amount of blood products transfused between the groups
时间窗: 24 hours
To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
次要结局
- Comparison in the amount of FFP transfused between the groups(24 hours)
- Transfusion related side effects(5 days)
- Comparison between blood products costs between groups(24 hours)
- Post-procedure bleeding(24 hours)
- Comparison in the amount of Cryoprecipitate transfused between the groups(24 hours)
- Comparison in the amount of Platelet transfused between the groups(24 hours)