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Use of ROTEM (Test) for Liver disease

Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures:A Randomised Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049779
Enrollment
90
Registered
2023-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K745- Biliary cirrhosis, unspecified

Interventions

Intervention1: 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/k

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children 6m- 18years of age 2. Histologic or image proven liver cirrhosis of any etiology 3. Listed for an invasive procedure Procedures 1. Central venous cannulation 2. Haemodialysis catheter 3. Ascitic or Pleural tapping 4. EVL/EST 5. TIPPS 6. ERCP with sphicterotomy 7. PCD Insertion 8. Biopsies other than liver biopsy : INR >2.5 and/or PLT count 20,000/mm3- 50,000/mm3 9. Those listed for Liver Biopsy: INR >2 and/or PLT count 20-50,000/mm3

Exclusion criteria

Exclusion criteria: 1. Anti platelet or anti coagulant therapy in the previous 7 days 2. Patients with clinical evidence of DIC and/or active bleeding 3. Hemodialysis in the past 7 days

Design outcomes

Primary

MeasureTime frame
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 cirrhosisTimepoint: 1 day

Secondary

MeasureTime frame
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 cirrhosisTimepoint: 1 day;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 cirrhosisTimepoint: 1 day;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.Timepoint: 1 day;The bleeding rate will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 5 day;The rate of transfusion reactions will be significantly less in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosisTimepoint: 5 day

Countries

India

Contacts

Public ContactDr Seema Alam

Institute of Liver and Biliary Sciences

seema_alam@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 4, 2026