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Rotational Thromboelastometry Guided Blood Component versus conventional blood product transfusion to prevent bleeding in children with liver involvement undergoing invasive tests

Phase 3
Completed
Conditions
Health Condition 1: K740- Hepatic fibrosis
Registration Number
CTRI/2020/11/029132
Lead Sponsor
ILBS hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison in the amount of blood products transfused between the groups <br/ ><br>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 <br/ ><br>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 Outcome Measures
NameTimeMethod
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