Hb Scope: A Multi-Center Validation Trial

China Medical University

Status: Completed

Conditions: Hemodialysis; Hemoglobin

Treatments: Other: Hb Scope APP

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05852184

T-CMUH-29745

Details and patient eligibility

About

The global prevalence of end-stage renal disease (ESRD) was estimated ranging 5.3 to 9.7 million patients in 2017 and is a major healthcare cost driver in both developed and developing economies. The majority of patients with ESRD, approximately 90%, received in-center maintenance hemodialysis (HD). Although HD patients are under the close supervision of a nephrologist, they are vulnerable to anemia and substantial hemoglobin (Hb) variability, which are controversially associated with poor clinical outcomes, such as all-cause mortality. The contemporary narrow target hemoglobin level recommended in the KDIGO and KDOQI guidelines, despite the ongoing debates, poses a crucial challenge in maintaining the optimal hemoglobin level in HD patients.

The Big Data Center at China Medical University Hospital (CMUH) has developed a tool, Hb Scope APP, that can use the color of the HD tubing to predict real-time Hb levels by leveraging the smartphone's camera capacity and machine learning (ML) technology. The performance of the Hb Scope ML algorithm in predicting Hb > 10 g/dL can reach an accuracy of 0.93 and an AUROC of 0.99 in the testing dataset. This opens an opportunity to establish a vibrant digital ecosystem for automatic anemia management.

Innovative ML tools must be appropriately regulated before these algorithms are adopted into clinical practice. Therefore, in the current validation study, we propose to do a multicenter validation trial for validating whether the Hb predicted by Hb Scope APP can achieve an area under the receiver operating curve (AUROC) of at least 0.80 in the adult HD populations from CMUH, Asia University Hospital (AUH) in Taiwan, and SEHA Kidney Care (SKC)-Central in the United Arab Emirates.

Enrollment: 504 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

504 participants in 3 patient groups

CMUH

Description:

Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at CMUH.

Treatment:

Other: Hb Scope APP

AUH

Description:

Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at AUH.

Treatment:

Other: Hb Scope APP

SKC-Central

Description:

Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at SKC-Central.

Treatment:

Other: Hb Scope APP