Global Coagulation Assessment in Portal Vein Thrombosis and Budd-Chiari Syndrome
Liv-Thrombus
Prospective Evaluation of Coagulation Status and Thromboelastometry Guided Management of Genetic and Acquired Thrombophilia in Patients With Portal Vein Thrombosis and Budd-Chiari Syndrome
1 other identifier
observational
300
1 country
1
Brief Summary
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. \[13\]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2021
CompletedFirst Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2024
CompletedFebruary 13, 2024
February 1, 2024
3 years
November 3, 2021
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Clinical presentation
Number of participants with clinical and imaging evidence of PVT and HVOTO in our patient population
At enrolment
Clinical presentation- Extent of disease
Grading of PVT and HVOTO in our patient population
At enrolment
Occurrence of new thrombotic complications
Description of new sites of thrombosis spectrum of PVT and HVOTO in our patient population
At enrolment-3 years
Occurrence of all thrombotic complications after anticoagulation
Description of new sites of thrombosis spectrum of PVT and HVOTO after anticoagulation
At enrolment-3 years
Comparison of performance of standard coagulation tests vs. global coagulation tests to determine the hypercoagulable defect
PT aPTT INR
At enrolment
Comparison of performance of global coagulation tests to determine the hypercoagulable defect
ROTEM/Sonoclot
At enrolment
Secondary Outcomes (6)
Assessment of genetic predisposition of hypercoagulable states in PVT and HVOTO
At enrolment
Assessment of genetic predisposition of hypercoagulable states in PVT and HVOTO
At enrolment
Assessment of genetic predisposition of hypercoagulable states in PVT and HVOTO
At enrolment
Assessment of genetic predisposition of hypercoagulable states in PVT and HVOTO
At enrolment
Occurrence of new hemorrhagic complications
At enrolment-3 years
- +1 more secondary outcomes
Study Arms (2)
PVT
Portal Vein Thrombosis (PVT) refers to partial or complete occlusion of the portal vein lumen by a blood clot or its replacement by multiple collateral vessels with the hepato-petal flow, commonly known as 'portal cavernoma.' 240 patients to be recruited
HVOTO
Occlusion of two or more hepatic veins. 100 patients
Interventions
ROTEM/ Sonoclot tests will be done in all patients at enrolment and after initiating anticoagulation in those who are eligible for the same.
Tests for JAK2 mutation, CAL R mutation and Factor V Leiden mutation will be done.
Antithrombin III, Protein C, Protein S, Factor VIII, VWF using commercial assays
Eligibility Criteria
All patients with PVT and HVOTO fitting the inclusion criteria will be prospectively enrolled in the study
You may qualify if:
- Gender: Either gender
- Age:18 - 65 years of age
- Patient with portal vein thrombosis documented on imaging (USG with color doppler, CECT abdomen and CEMRI abdomen
You may not qualify if:
- Patients who do not consent to the study.
- Patient with pregnancy and lactation
- Patients with a history of blood transfusions in the last two weeks
- Patients who are too sick to undergo screening tests.
- Patients on hemodialysis
- Chronic heart failure and chronic pulmonary or end-stage renal disease
- Patients who are on plasma therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, 160012, India
Biospecimen
Blood and serum samples for thrombophilia evaluation.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madhumita Premkumar, MD DM
Post Graduate Institute of Medical Education and Research, Chandigarh
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 3, 2021
First Posted
November 17, 2021
Study Start
October 15, 2021
Primary Completion
October 15, 2024
Study Completion
October 15, 2024
Last Updated
February 13, 2024
Record last verified: 2024-02