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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 8, 2023

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ClinConnect Summary

This clinical trial is studying a new method called ROTEM (Rotational Thromboelastometry) to help guide blood transfusions for children with decompensated cirrhosis who need to undergo certain medical procedures. Decompensated cirrhosis is a serious liver condition that can make it hard for the body to control bleeding and clotting. Traditionally, doctors have relied on tests that measure how long it takes for blood to clot and how many platelets (cells that help blood clot) are in the blood. However, these tests may not always provide the best guidance, as they can sometimes lead to unwanted blood clots. ROTEM offers a more detailed picture of how the blood is clotting in real-time, which may help doctors make better decisions about whether and how much blood product to give before a procedure.

To be eligible for this trial, children aged 6 months to 18 years who have been diagnosed with liver cirrhosis and are scheduled for specific invasive procedures, like central line placement or certain biopsies, may participate. Participants will undergo ROTEM testing to assess their transfusion needs before their procedure. The goal of the study is to see if using ROTEM can improve the safety and effectiveness of blood transfusions during these critical situations. If you think your child might qualify, the medical team can provide more information about what to expect and how this trial could help improve care for children with similar conditions.

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Eligibility criteria

• Inclusion Criteria:
• • 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
• 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