A tool to predict hemoglobin levels in hemodialysis patients
Hb Scope: A Multi-Center Validation Trial
This study is testing a new app that uses your smartphone camera to predict hemoglobin levels in patients on hemodialysis to see if it can help manage their health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 504 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 3 sites (Taichung and 2 other locations) |
| Trial ID | NCT05852184 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Hb Scope APP, a novel tool developed to predict real-time hemoglobin levels in patients undergoing maintenance hemodialysis. By utilizing the smartphone camera and machine learning, the app analyzes the color of hemodialysis tubing to provide accurate hemoglobin readings. The study will involve patients from multiple centers who meet specific eligibility criteria, focusing on those receiving regular hemodialysis treatment. The goal is to address the challenges of hemoglobin variability and improve clinical outcomes for end-stage renal disease patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 20-90 years who are receiving regular maintenance hemodialysis through arteriovenous access.
Not a fit: Patients who do not have a recent hemoglobin level recorded or who are not willing to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could enhance the management of hemoglobin levels in hemodialysis patients, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While the approach of using smartphone technology for health monitoring is gaining traction, this specific application for predicting hemoglobin levels in hemodialysis patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients receiving regular maintenance HD in the three participating sites; AND * Aged 20-90 years old; AND * Received regular HD through an arteriovenous (AV) fistula or AV graft access; AND * Use the Fresenius HD machine 4008/4008S and 5008/5008S. Exclusion Criteria: * Do not have last Hb level from labs within 1 month prior; OR * Do not receive blood drawn for the true Hb level or do not have the true Hb level on the date of image taking by Hb Scope APP; OR * Do not agree to participate.
Where this trial is running
Taichung and 2 other locations
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Asia University Hospital — Taichung, Taiwan (Recruiting)
- SHEA Kidney Care — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Chin-Chi Kuo, MD, PhD
- Email: fenderkuo@gmail.com
- Phone: +886422052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.