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Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures.

NCT05734001 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-03-19

No results posted yet for this study

Summary

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

Conditions

  • Decompensated Cirrhosis

Interventions

DIAGNOSTIC_TEST

ROTEM Tests

This group will undergo ROTEM based correction. ROTEM bcorrection will be based on the following protocol 1. EXTEM CT \> 80 sec - FFP will be transfused at 15 ml/kg MCF \< 35 mm- Platelet will be transfused at 10 ml/kg 2. FIBTEM MCF \< 7 mm- Cryoprecipitate will be transfused at 5 ml/kg

DIAGNOSTIC_TEST

Conventional Haemostatic Tests

To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either FFP, Platelet or Cryoprecipitate based on the following protocol 1. If INR: \> 2.5 FFP will be transfused at 15 ml/kg 2. If Platelet Count is 20,000/mm3-50,000/mm3 RDPC will be transfused at 10 ml/kg 3. If Fibrinogen \< 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734001 on ClinicalTrials.gov