Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05582447 · ClinicalTrials.gov registry record
Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease
A clinical trial of Cholestasis and Red Cell Membrane and Enzyme Abnormalities, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT05582447 is a study of Cholestasis and Red Cell Membrane and Enzyme Abnormalities that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants, below the 151-participant average among 6 other Cholestasis trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05582447, a study of Cholestasis and Red Cell Membrane and Enzyme Abnormalities, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER ektacytometry of red blood cells
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2027-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05582447
The ClinicalTrials.gov registry entry for NCT05582447 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 6 other Cholestasis trials with a reported enrollment target (74% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cholestasis appearing as the primary indexed condition, and to 1 intervention - of which ektacytometry of red blood cells is the first listed.
NCT05582447 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05582447 about?
NCT05582447 is a clinical study titled "Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease". 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, Al...
What is the current status of trial NCT05582447?
This trial is currently active not recruiting. The enrollment target is 40 participants. The study started on 2018-04-17. Estimated completion is 2027-12-31.
What conditions does trial NCT05582447 study?
This clinical trial studies the following conditions: Cholestasis, Red Cell Membrane and Enzyme Abnormalities.
What interventions are being tested in trial NCT05582447?
The interventions under investigation include: ektacytometry of red blood cells (OTHER).
Who is sponsoring clinical trial NCT05582447?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05582447 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cholestasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Linerixibat Long-term Safety, and Tolerability Study
ACTIVE NOT RECRUITING · Phase 3
-
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
COMPLETED · NA
-
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
COMPLETED · NA
-
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
COMPLETED · Phase 3
-
Gabapentin to Treat Itch in Patients With Liver Disease
COMPLETED · Phase 3
-
Cholestasis Prevention: Efficacy of IV Fish Oil
COMPLETED · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.