HemoglobinNCT05852184
Hb Scope: A Multi-Center Validation Trial
An observational study of Hemoglobin and Hemodialysis, run by China Medical University Hospital at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hemoglobin, Hemodialysis
- What is being tested?
- Hb Scope APP
- How many people
- 504 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving regular maintenance HD through an arteriovenous (AV) fistula or AV graft access in the three participating sites.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Taiwan2 sites
China Medical University Hospital
Taichung, 404
Asia University Hospital
Taichung
About this study
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
- Being tested
- Hb Scope APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hb Scope APPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CMUH | Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at CMUH. Receives: Other: Hb Scope APP | |
| AUH | Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at AUH. Receives: Other: Hb Scope APP | |
| SKC-Central | Adult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at SKC-Central. Receives: Other: Hb Scope APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 10 g/dL.
The targeted area under the receiver operating curve (AUROC) is 0.80.
Measured: 2 months
Secondary outcomes (3)
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of < 8 g/dL.
The targeted area under the receiver operating curve (AUROC) is 0.80.
Measured: 2 months
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 12 g/dL.
The targeted area under the receiver operating curve (AUROC) is 0.80.
Measured: 2 months
Consistency between the lab-derived and Hb Scope-derived Hb continuous value.
The targeted correlation coefficient is 0.70.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jul 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, SEHA Kidney Care, Asia University Hospital
- Responsible party
- Principal investigator, Chin-Chi Kuo, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852184
- Sponsor's protocol ID
- T-CMUH-29745
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hb Scope: A Multi-Center Validation Trial
- ClinicalTrials.gov ID
- NCT05852184
- Acronym / sponsor ID
- T-CMUH-29745
- Conditions
- Hemoglobin, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, SEHA Kidney Care, Asia University Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CMUH | – | Other: Hb Scope APPAdult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at CMUH. |
| AUH | – | Other: Hb Scope APPAdult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at AUH. |
| SKC-Central | – | Other: Hb Scope APPAdult patients who receive maintenance hemodialysis through an arteriovenous (AV) fistula or AV graft access at SKC-Central. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving regular maintenance HD through an arteriovenous (AV) fistula or AV graft access in the three participating sites.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hb Scope APPThe 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. | Other | AUH, CMUH, SKC-Central |
Primary outcome
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 10 g/dL.
Time frame: 2 months
The targeted area under the receiver operating curve (AUROC) is 0.80.
3 secondary outcomes
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of < 8 g/dL.
Time frame: 2 months
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 12 g/dL.
Time frame: 2 months
Consistency between the lab-derived and Hb Scope-derived Hb continuous value.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. Will not make IPD available to other researchers.
Related trials for Hemoglobin
Not yet recruitingObservational study
Glycemic Control in Leukemia Patients
Leukemia
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal
Recruiting
Blood Transfusion Strategies During Major Surgery
Perioperative Red Blood Cell Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobin and Hemodialysis, run by China Medical University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 10 g/dL. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.