Hb Scope: A Multi-Center Validation Trial

NCT ID: NCT05852184

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 504 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-01-31

Brief Summary

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.

Conditions

Hemoglobin; Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CMUH

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

Hb Scope APP

Intervention Type: OTHER

The study intervention is the Hb Scope APP, a camera-based real-time Hb estimation tool using a data collection function and a machine learning-based algorithm to analyze the image of HD tubing and output the estimated Hb value.

Our proposed Hb Scope APP can provide a non-invasive and real-time estimation of Hb level for detecting the alarming Hb status (i.e., <=10 g/dL) during every HD session. The software is for information management purposes only and is not intended for diagnostic use.

AUH

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

Hb Scope APP

Intervention Type: OTHER

The study intervention is the Hb Scope APP, a camera-based real-time Hb estimation tool using a data collection function and a machine learning-based algorithm to analyze the image of HD tubing and output the estimated Hb value.

Our proposed Hb Scope APP can provide a non-invasive and real-time estimation of Hb level for detecting the alarming Hb status (i.e., <=10 g/dL) during every HD session. The software is for information management purposes only and is not intended for diagnostic use.

SKC-Central

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

Hb Scope APP

Intervention Type: OTHER

The study intervention is the Hb Scope APP, a camera-based real-time Hb estimation tool using a data collection function and a machine learning-based algorithm to analyze the image of HD tubing and output the estimated Hb value.

Our proposed Hb Scope APP can provide a non-invasive and real-time estimation of Hb level for detecting the alarming Hb status (i.e., <=10 g/dL) during every HD session. The software is for information management purposes only and is not intended for diagnostic use.

Interventions

Hb Scope APP

The study intervention is the Hb Scope APP, a camera-based real-time Hb estimation tool using a data collection function and a machine learning-based algorithm to analyze the image of HD tubing and output the estimated Hb value.

Our proposed Hb Scope APP can provide a non-invasive and real-time estimation of Hb level for detecting the alarming Hb status (i.e., <=10 g/dL) during every HD session. The software is for information management purposes only and is not intended for diagnostic use.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

SEHA Kidney Care

UNKNOWN

Sponsor Role: collaborator

Asia University Hospital

UNKNOWN

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chin-Chi Kuo

Deputy Superintendent of Big Data Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Asia University Hospital

Taichung, , Taiwan

SHEA Kidney Care

Abu Dhabi, , United Arab Emirates

Countries

Taiwan; United Arab Emirates

Other Identifiers

T-CMUH-29745

Identifier Type: -

Identifier Source: org_study_id