Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Rotational Thromboelastometry: To prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol
Sponsors
ILBS hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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 PLT 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 EVL EST High risk of bleeding TIPPS ERCP with sphicterotomy PCD Insertion Biopsies other than liver biopsy AND Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR � 1.5- � 2.0 and/or PLT count 40,000/mm3- 60,000/mm3 and who are listed for Liver biopsy
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison in the amount of blood products transfused between the groups 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 To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-procedure bleeding Comparison of the number of patients having bleeding episodes after procedure between the study groupsTimepoint: 24 hours;Transfusion related side effects - To compare the rate of transfusion reactions in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 5 days;Comparison between blood products costs between groups To compare the cost of transfusion components incurred in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 24 hours;Comparison in the amount of Cryoprecipitate transfused between the groups To compare the amount of Cryoprecipitate transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 24 hours;Comparison in the amount of FFP transfused between the groups To compare the amount of FFP (ml/kg) transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 24 hours;Comparison in the amount of Platelet transfused between the groups To compare the amount of Platelet transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 24 hours | — |
Countries
India
Contacts
Public ContactArjun Maria
ILBS, Delhi
Outcome results
None listed