Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures:A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The amount of total component transfused (ml/kg) will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
研究概览
简要总结
Decompesated Cirrhosis is charecterised by decreased synthesis of both procoagulants and anticoagulants along with thrombocytopenia and a delicate balance exists bleeding and thrombosis in this condition. There is increase in Prothrombin Time (PT) in this condition, consequently guidelines recommend correction of International Normalised Ratio (INR) and platelete count by transfusion of Fresh Frozen Plasma (FFP) and platelet transfusion before invasive procedures to prevent bleeding complications. However PT and platelet count are not ideal tests to guide transfusion strategies as they do not take into account the relative deficiency of anticoagulant factors. Furthermore, cirrhotic patients have an excess of von Willebrand factors and Factor VIII which are prothrombotic. So FFP and platelet transfusions based on PT and platelet count can actually lead to a prothrombotic state. Viscoelastic assays like ROTEM measure the haemostatic process in real time by detecting the resistance to movement of an oscillating pin by the clotting blood. It has three componenets-EXTEM, which measures the extrinsic coagulation pathway, INTEM, which measures the intrinsic pathway and FIBTEM which measures fibrinogen. Two parameters of EXTEM indicate FFP and platelet requirement and should be able to guide transfusion therapy. The first is Clottting Time (CT), that is the latency time between the formation of the test and the clot formation as the tracing reaches 2 mm of amplitude and the second is Maximum Clot Formation (MCF), that is the greatest vertical amplitude of the tracing. While CT helps in guiding FFP transfusion, MCF guides platelet transfusion. Fibrinogen requirement is guided by MCF values of FIBTEM.
The aim of this study will be to compare the transfusion requirement, efficacy and safety of ROTEM in guiding the use of FFP, Platelet and cryoprecipitate transfusion before invasive procedures in children with decompensated cirrhosis before invasive procedures.
Project title:Rotational Thromboelastometry versus conventional haemostatic tests in children with Decompensated Cirrhosis undergoing invasive procedures: A Randomised Controlled Trial
Student PI name: Dr Snigdha Verma
详细描述
a) Single centre Randomised Control Trial
(b) Methodology:
- Study population : Children aged6months-18 years with Decompensated Cirrhosis with histologic or image proven liver cirrhosis of any etiology with INR >2.5 and/or PLT count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedure
- Low risk of bleeding
- Central venous cannulation
- Haemodialysis catheter
- Ascitic or Pleural tapping
- EVL
- EST
High risk of bleeding 6. TIPPS 7. ERCP with sphicterotomy 8. PCD Insertion 9. Biopsies other than liver biopsy
- Study design:Randomised Control Trial
- Study period: 2 year: October 2022 to October 2024
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6m- 18years of age
- •Histologic or image proven liver cirrhosis of any etiology
- •Listed for an invasive procedure Procedures
- •Central venous cannulation
- •Haemodialysis catheter
- •Ascitic or Pleural tapping
- •ERCP with sphicterotomy
- •PCD Insertion
- •Biopsies other than liver biopsy : INR >2.5 and/or PLT count 20,000/mm3- 50,000/mm3
- •Those listed for Liver Biopsy: INR >2 and/or PLT count 20-50,000/mm3
排除标准
- •Anti platelet or anti coagulant therapy in the previous 7 days
- •Patients with clinical evidence of DIC and/or active bleeding
- •Hemodialysis in the past 7 days
研究组 & 干预措施
Conventional Haemostatic Tests
Conventional Haemostatic Tests:
- If INR: > 2.5 FFP will be transfused at 15 ml/kg
- If Platelet Count is 20,000/mm3-50,000/mm3 RDPC will be transfused at 10 ml/kg
- If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg
干预措施: Conventional Haemostatic Tests (Diagnostic Test)
ROTEM Based tests
The second group will undergo ROTEM based correction. ROTEM correction will be based on the following protocol :
- EXTEM CT > 80 sec - FFP will be transfused at 15 ml/kg MCF < 35 mm- Platelet will be transfused at 10 ml/kg
- FIBTEM MCF < 7 mm- Cryoprecipitate will be transfused at 5 ml/kg
干预措施: ROTEM Tests (Diagnostic Test)
结局指标
主要结局
The amount of total component transfused (ml/kg) will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
时间窗: 1 day
次要结局
- The rate of transfusion reactions will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis(5 days)
- The amount of Platelet (ml/kg) transfused will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis.(1 day)
- The amount of cryoprecipitate (ml/kg) transfused will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis(1 day)
- The bleeding rate will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis(5 days)
- The amount of FFP (ml/kg) transfused will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis(1 day)