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NCT05734001
Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures.
Conditions: Decompensated Cirrhosis
Sex: All
Ages: 6 Months – 18 Years
Phase: NA
Enrollment: 90
Sponsor: Institute of Liver and Biliary Sciences, India
Location: India
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 TrialStudent PI name: Dr Snigdha Verma
Eligibility Criteria
Inclusion Criteria:Inclusion CriteriaChildren 6m- 18years of ageHistologic or image proven liver cirrhosis of any etiologyListed 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/mm3Exclusion Criteria:Anti platelet or anti coagulant therapy in the previous 7 daysPatients with clinical evidence of DIC and/or active bleedingHemodialysis in the past 7 days
Source: ClinicalTrials.gov (NCT05734001). StuddyBuddy aggregates publicly available trial information.