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

NCT05734001 | Recruiting

• 1 other identifier: ILBS-DecompCirrhosis-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (5)

• 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

• 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 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

Study Arms (2)

Conventional Haemostatic Tests

ACTIVE COMPARATOR

Conventional Haemostatic Tests: 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

Diagnostic Test: Conventional Haemostatic Tests

ROTEM Based tests

EXPERIMENTAL

The second group will undergo ROTEM based correction. ROTEM correction 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: ROTEM Tests

Interventions

ROTEM Tests DIAGNOSTIC_TEST

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

ROTEM Based tests

Conventional Haemostatic Tests DIAGNOSTIC_TEST

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

Conventional Haemostatic Tests

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 6m- 18years of age
• Histologic or image proven liver cirrhosis of any etiology
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

RECRUITING

Central Study Contacts

Snigdha Verma

CONTACT

7427872290; dr.snigdha1@gmail.com

Dr.Seema Alam

CONTACT

9540951008; seema_alam@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: November 18, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

IN (1)