Assessing blood clotting in patients with portal vein thrombosis and Budd-Chiari syndrome
Prospective Evaluation of Coagulation Status and Thromboelastometry Guided Management of Genetic and Acquired Thrombophilia in Patients With Portal Vein Thrombosis and Budd-Chiari Syndrome
This study is testing new ways to check blood clotting in patients with portal vein thrombosis and Budd-Chiari syndrome to see how it affects their treatment and understand their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pgimer |
| Locations | 1 site (Chandigarh, Choose Any State/Province) |
| Trial ID | NCT05123326 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate global coagulation tests in patients with portal vein thrombosis (PVT) and Budd-Chiari syndrome. It will utilize point-of-care tests like ROTEM and Sonoclot to assess clot strength and formation time, which are crucial for monitoring anticoagulant therapy. Additionally, the study will investigate the prevalence of genetic mutations associated with thrombophilia in this patient population and examine the incidence of PVT in individuals exposed to COVID-19. The findings could enhance understanding of coagulation in liver disease and improve patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 with documented portal vein thrombosis.
Not a fit: Patients who are pregnant, have recently received blood transfusions, or are too ill to undergo screening tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and treatment strategies for patients with portal vein thrombosis and related conditions.
How similar studies have performed: While the approach of using global coagulation tests is gaining interest, this specific study's focus on PVT and Budd-Chiari syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Chandigarh, Choose Any State/Province
- Postgraduate Institute of Medical Education and Research — Chandigarh, Choose Any State/Province, India (Recruiting)
Study contacts
- Principal investigator: Madhumita Premkumar, MD DM — Post Graduate Institute of Medical Education and Research, Chandigarh
- Study coordinator: Madhumita Prem Kumar, MD DM
- Email: drmadhumitap@gmail.com
- Phone: 0172-2754777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.