NCT05582447

Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease

Active, enrolled Last updated 6 February 2026

What this trial tests

trial testing ektacytometry of red blood cells in Cholestasis in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 April 2018

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	40
Start date	17 April 2018
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• ektacytometry of red blood cells

Conditions studied

• Cholestasis — all drugs for Cholestasis →
• Red Cell Membrane and Enzyme Abnormalities — all drugs for Red Cell Membrane and Enzyme Abnormalities →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

1 and older, any sex, with Cholestasis or Red Cell Membrane and Enzyme Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective:

The investigators propose to perform ektacytometry on 20 pediatric patients over age one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl. The most common diagnoses will be extrahepatic biliary atresia, progressive familial intrahepatic cholestasis, Alagille syndrome, autoimmune hepatitis, primary sclerosing cholangitis, and parenteral nutrition-associated cholestasis. The investigators will correlate the osmotic fragility and deformability with direct bilirubin levels, serum cholesterol levels, serum bile acid levels, and vitamin E levels.

Design/Methods:

This pilot study will be a single center, prospective cross-sectional investigation of red blood cell ektacytometry in pediatric patients with extrahepatic cholestasis who are followed at Cincinnati Children's Hospital Medical Center. The study will include all participants with cholestasis regardless of the etiology in order to maximize the number of participants. While the population will be heterogeneous, the investigators will stratify participants according to diagnosis, recognizing that only a few participants may fall into each diagnostic category. Ektacytometry will be the method utilized to measure osmotic fragility and deformability of the RBC membrane. The ektacytometry of red cells from cholestatic patients will be compared to that of red cells obtained from contemporaneous age-matched controls recruited among patients without liver disease or red cell membrane defects undergoing blood sampling for evaluation of other entities including but not confined to functional abdominal pain.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Red cell abnormalities characterized by ektacytometry in children with cholestasis.
   Kocoshis TS, Kalfa TA, Miethke AG, Balistreri WF, et al · · 2024 · PMID 38040987 · DOI 10.1038/s41390-023-02899-2