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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Institute of Liver and Biliary Sciences
RECRUITING
New Delhi
Contact Information
Primary
Snigdha Verma
dr.snigdha1@gmail.com
7427872290
Backup
Dr.Seema Alam
seema_alam@hotmail.com
9540951008
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 90
Treatments
Active_comparator: Conventional Haemostatic Tests
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
Experimental: ROTEM Based tests
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
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov

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