NCT05123326: Liv-Thrombus

Global Coagulation Assessment in Portal Vein Thrombosis and Budd-Chiari Syndrome

Status unknown Last updated 13 February 2024

What this trial tests

trial testing Rotational thromboelastometry in Hepatic Vein Thromboses in 300 participants. Status unknown.

Timeline

15 October 2021

Primary endpoint
15 October 2024

15 October 2024

Quick facts

Lead sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	15 October 2021
Primary completion	15 October 2024
Estimated completion	15 October 2024
Sites	1 location across India

Drugs / interventions tested

• Rotational thromboelastometry
• Genetic tests for Thrombophilia
• ELISA tests/ Functional assays

Conditions studied

• Hepatic Vein Thromboses — all drugs for Hepatic Vein Thromboses →
• Hepatic Venous Outflow Obstruction — all drugs for Hepatic Venous Outflow Obstruction →
• Portal Vein Thrombosis — all drugs for Portal Vein Thrombosis →
• Portal Hypertension, Noncirrhotic — all drugs for Portal Hypertension, Noncirrhotic →

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

Adults 18 to 65, any sex, with Hepatic Vein Thromboses or Hepatic Venous Outflow Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Portal vein thrombosis is defined as partial or complete occlusion of the portal vein lumen by the blood clot or its replacement by multiple collateral vessels with the hepato-petal flow, known as 'portal cavernoma'. \[1,2\] Based on the published literature, 15-25% of patients with cirrhosis have portal vein thrombosis (PVT) \[3\], and 35-50% of patients with hepatocellular carcinoma (HCC) have malignant PVT \[4\] compared to 1-3.8 per 100,000 patients in the general population. \[5\] The reported cumulative incidence of PVT in patients of Child-Pugh A and B is 4.6% and 10.7% at 1 and 5 years respectively with higher incidence among those with decompensated disease or with an underlying hypercoagulable disorder. \[6\]. Similarly, the prevalence of PVT in compensated cirrhosis is around 1% which increases to 8 - 25% in liver transplant (LT) candidates and 40% in patients with hepatocellular carcinoma (HCC) \[7,8\]. Based on the published literature 7-9 % of all chronic liver disease patients have hepatic vein outflow tract obstruction (HVOTO) in the Indian population. \[9\] HVOTO is defined as obstruction to hepatic venous outflow at any site from the right atrium inlet to the small hepatic venules. The Budd-Chiari syndrome (BCS) results from occlusion of one or more hepatic veins (HV) and/or the inferior vena cava (IVC). In the West, the most common cause is HV occlusion by thrombosis. More recent Indian studies have however shown that isolated HV and combined IVC+HV obstruction are now more common. \[10\]

In the post COVID-19 era, there has been great interest in the prothrombotic states associated with the SARS-Cov-2 virus infection, and the adverse effects of some vaccines. \[11\] With the availability of better molecular tests for hypercoagulable states, use of global coagulation tests (GCT) like rotational thromboelastometry (ROTEM), thromboelastography (TEG) and Sonoclot, use of therapeutic procedures like Transjugular intrahepatic portosystemic shunt (TIPS), availability of novel oral anticoagulants (NOAC), the natural course of disease can be changed with good outcomes. \[12\] Standard Coagulation tests (SCTs) like PT, aPTT, and platelet count are not predictive of bleeding or coagulation risk as they exclude the cellular elements of hemostasis and are unable to assess the effect of thrombomodulin and cannot assess the stage of the coagulation pathway which is affected. Global coagulation tests provide dynamic information on the coagulation pathway that is not available from conventional tests. \[13\]

Publications & conference data

No peer-reviewed publications indexed yet for this trial.