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Tiny blood cells may reveal clues about liver disease in kids

NCT ID NCT05582447

Knowledge-focused Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looks at red blood cells in 20 children with cholestatic liver disease and compares them to healthy children. Researchers use a special test called ektacytometry to measure how fragile and flexible the red blood cells are. The goal is to see if liver problems change red blood cell properties, which could help doctors understand the disease better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how liver disease affects red blood cells, potentially leading to improved monitoring or care.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to all children with liver disease. It is observational and not testing a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be recruited from Cincinnati Children's Hospital hepatology and gastroenterology clinics. Pediatric patients over age one without cholestatic liver disease and pediatric patients over the age of one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Disease Cohort * Age greater than one year old * Direct bilirubin level of \>2 mg/dl. * No known congenital red cell membrane defect * Controls * Age matched to disease cohort * No evidence for cholestatic liver disease * No known congenital red cell membrane defect Exclusion Criteria: * Disease Cohort * Parental refusal * Age \<1 year old. * Known congenital red cell membrane defect * Controls * Parental refusal * Age \<1 year old. * Known congenital red cell membrane defect * Cholestatic liver disease

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Conditions

The condition(s) this trial relates to.

cholestasis erythrocyte disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholestasis Red cell membrane and enzyme abnormalities

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.