Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06771011

Prospective Comparative Validation Study of RUCAM and RECAM

Led by Beijing Friendship Hospital · Updated on 2025-01-13

407

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.

CONDITIONS

Official Title

Prospective Comparative Validation Study of RUCAM and RECAM

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years old
  • Acute liver injury within 3 months of onset with biochemical criteria: ALT ≥5 times upper limit of normal; ALP ≥2 times upper limit of normal; or ALT ≥3 times upper limit of normal and total bilirubin ≥2 times upper limit of normal
  • Clear history of medication including timing, drug names, doses, and reasons for use; detailed information on traditional Chinese medicine components if applicable
  • Complete key data required for calculating RUCAM and RECAM scores
  • Follow-up confirming the cause of acute liver injury as drug-induced liver injury or specified liver diseases such as acute viral hepatitis, alcoholic liver disease, autoimmune hepatitis, biliary diseases, hypoxic-ischemic hepatitis, or congestive liver disease
Not Eligible

You will not qualify if you...

  • Inability to accurately calculate incubation period due to unclear medication or illness onset dates
  • Unclear identification of the causative drug, described only generally without specific names
  • Missing biochemical data preventing assessment of liver biochemistry improvement after drug withdrawal
  • Undetermined cause of acute liver injury
  • Liver injury caused by acetaminophen overdose
  • Toxic liver diseases such as mushroom poisoning or chemical poisonings
  • Previous liver or bone marrow transplantation
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Friendship Hospital

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

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Research Team

X

Xinyan Zhao

CONTACT

Y

Yao Meng

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Prospective Comparative Validation Study of RUCAM and RECAM | DecenTrialz