Whether medical treatment based on genetic testing has any impact of the bleeding and treatment costs when compared to usual care without genetic testing
Phase 4
- Conditions
- Health Condition 1: I820- Budd-Chiari syndrome
- Registration Number
- CTRI/2019/06/019648
- Lead Sponsor
- Dr Akash Shukla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients who are newly diagnosed for Budd Chiari and are warfarin naive
2. Aged 18 years to 60 years of either gender
3. Patients willing to give voluntarily written informed consent
4. Patient willing to comply with protocol requirements
Exclusion Criteria
1.Genotype (CYP2C9 and VKORC1) known to participant from prior testing or available in medical record.
2.Pregnancy or lactation
3.Any other clinical condition as per physicianâ??s judgment which compromises safety of the participant or credibility of the data.
4.Patients with contraindications to warfarin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients with bleeding in the genotyping group and standard group.Timepoint: every 3 months for a period of 24 months
- Secondary Outcome Measures
Name Time Method Incidence of Thrombosis of stent / hepatic veinTimepoint: 24 months;Incremental cost effectiveness ratioTimepoint: 24 months;Number of major and minor bleedsTimepoint: 24 months;number of times a patient is in therapeutic range (TR)Timepoint: over a period of 24 months