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The effect of using automated APRI calculation in pathology on diagnosis of liver cirrhosis and linkage to care: The Cirrhosis Automated APRI Screening Evaluation (CAPRISE) Study

The effect of using automated APRI calculation in pathology on diagnosis of liver cirrhosis and linkage to care: The Cirrhosis Automated APRI Screening Evaluation (CAPRISE) Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000295640
Acronym
CAPRISE
Enrollment
78947
Registered
2023-03-17
Start date
2023-08-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

None listed

Brief summary

Finding people with chronic liver disease and silent liver cirrhosis (scarring) who are at risk of liver failure and liver cancer is a critical public health issue. The AST-to-platelet ratio index (APRI) determines the risk of liver cirrhosis and is calculated using routine blood tests. In this study, we determine whether an innovative cirrhosis screening program of automated APRI calculation and provision of liver disease education information including a weblink for Fibroscan referral on routine pathology blood test results increases liver cirrhosis diagnosis and linkage to specialist care. We hypothesise that the inclusion of automated fibrosis scores will lead to an increased recognition of individual's at risk of significant fibrosis and improved linkage to care.

Interventions

The intervention will involve the automated calculation of: 1) Aspartate aminotransferase (AST) to platelet ratio index (APRI) = (AST level/ AST upper limit of normal)/platelet count)*100, where the AST upper limit of normal is lab and sex based, and 2) Fibrosis-4 (FIB-4) score calculation and reporting = (age*AST)/(platelet count*sqrt(ALT) Reporting of these values will be in a separate report of 'Fibrosis scores' that will be available if a Full Blood Count (FBC) and Liver tests (LFTs) have

The intervention will involve the automated calculation of: 1) Aspartate aminotransferase (AST) to platelet ratio index (APRI) = (AST level/ AST upper limit of normal)/platelet count)*100, where the AST upper limit of normal is lab and sex based, and 2) Fibrosis-4 (FIB-4) score calculation and reporting = (age*AST)/(platelet count*sqrt(ALT) Reporting of these values will be in a separate report of 'Fibrosis scores' that will be available if a Full Blood Count (FBC) and Liver tests (LFTs) have been performed. Recommendations based on repeated, elevated values will also be included on the report with APRI >1.0 and FIB-4>2.67 for consideration of referral for further investigation of chronic liver disease risk and specialist referral if age appropriate and not already known to the service provider. Primary care physicians utilising the recommendations will have the opportunity to discuss these results with individuals prior to referral and counselling about risk of liver disease that requires further work up prior to diagnosis.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

All individuals aged 18 years and over who have liver function tests and full blood count performed at St Vincent’s Pathology between 9 August, 2022-December 31, 2023

Exclusion criteria

Blood tests performed during a hospital inpatient stay, defined by St Vincent’s Pathology records (blood collection site).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026