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Whether medical treatment based on genetic testing has any impact of the bleeding and treatment costs when compared to usual care without genetic testing

Evaluation of the utility of genotyping in patients with Budd Chiari Syndrome Versus Standard of care to assess impact on bleeding and costs - A randomized control trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019648
Enrollment
120
Registered
2019-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I820- Budd-Chiari syndrome

Interventions

Intervention1: Genotyping arm: Pharmacogenetic analysis for mutations in VKORC1 and CYP2C9 gene and subsequent warfarin therapy Control Intervention1: Non-Genotyping arm: Usual standard of care and wa

Sponsors

Dr Akash Shukla
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
proportion of patients with bleeding in the genotyping group and standard group.Timepoint: every 3 months for a period of 24 months

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Akash Shukla

Lokmanya Tilak Municipal Medical College & General Hospital

drakashshukla@yahoo.com9869256376

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026