Upper Gastrointestinal Bleeding (UGIB)UGISNCT07458178
A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding
An observational study of Upper Gastrointestinal Bleeding (UGIB) and High Risk Bleeding, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Upper gastrointestinal bleeding (UGIB) remains a common and potentially life-threatening emergency condition requiring early risk stratification to guide clinical management. Although several validated scoring systems such as Rockall, Glasgow-Blatchford Score (GBS), AIMS65, H3B2, ABC, ABL, and Pre-endoscopic Rockall… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB), High Risk Bleeding
- How many people
- 312 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Demographic characteristics, presenting complaints, comorbid conditions, regularly used medications, mental status, vital signs, laboratory values, admission locations, blood transfusion requirements, endoscopic hemostasis procedures, radiological interventions, surgical procedures, length of stay (LOS), readmissions, and in-hospital mortality data were obtained from the electronic patient record system. All data were recorded by a single physician using a pre-prepared data collection form.
Who may be able to join
- Age ≥18 years
- Consecutive patients presenting to the emergency department between January 2024 and January 2026
- Clinical presentation suggestive of upper gastrointestinal bleeding, including hematemesis, melena, or hematochezia suspected to originate from the upper gastrointestinal tract due to rapid intestinal transit
- Patients who underwent upper gastrointestinal endoscopy during the index hospitalization
- Presence of endoscopic findings confirming upper gastrointestinal pathology
- Availability of complete clinical, laboratory, and outcome data in the hospital information management system
- Patients evaluated and managed in the Emergency Department of İzmir Atatürk Training and Research Hospital
Who cannot join
- Age <18 years
- Patients presenting with cardiac arrest at admission
- Intubated patients at the time of emergency department presentation
- Presence of concomitant active infectious diseases
- Patients diagnosed with esophageal variceal bleeding
- Use of medications known to increase serum lactate levels, including:
Show all 13Show fewer
- metformin
- β2-agonists
- methotrexate
- zidovudine
- linezolid
- Patients with missing or incomplete clinical or laboratory data
- Patients whose hospital outcomes could not be determined during follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Faculty of Medicine
Izmir
About this study
Official title: A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding and Comparison of the Found Score With Scoring Systems in the Literature
Upper gastrointestinal bleeding (UGIB) remains a common and potentially life-threatening emergency condition requiring early risk stratification to guide clinical management. Although several validated scoring systems such as Rockall, Glasgow-Blatchford Score (GBS), AIMS65, H3B2, ABC, ABL, and Pre-endoscopic Rockall (Pre-RS) are widely used, their discriminative performance for identifying patients at high clinical risk varies across populations.
This retrospective, single-center observational study included 312 adult patients admitted to the emergency department between January 2024 and January 2026 with clinical manifestations of UGIB. Patients were categorized into high-risk and low-risk groups based on clinically significant outcomes, including transfusion requirement, endoscopic/radiological/surgical intervention, intensive care unit admission, rebleeding, or in-hospital mortality.
Read more
The primary objective was to develop a novel risk score (HOLD_B), derived from independent predictors identified through multivariable logistic regression analysis. Receiver Operating Characteristic (ROC) curve analysis was used to determine optimal cut-off values for continuous predictors and to evaluate discriminative performance. The newly developed score was compared with established scoring systems using area under the curve (AUC) analysis and DeLong's test for pairwise comparisons.
The study aims to provide a simplified and clinically applicable risk stratification tool for early identification of high-risk UGIB patients in the emergency department setting.
- Keywords
- Upper Gastrointestinal Bleeding, risk scores, high risk bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| upper gastrointestinal bleeding | clinical manifestations of upper gastrointestinal bleeding (UGIB) and subsequently hospitalized during | |
| High-Risk upper gastrointestinal bleeding group | Patients were classified as high risk if they met at least one of the following criteria during hospitalization: Requirement for blood transfusion Endoscopic hemostatic intervention Radiological intervention Surgical intervention Intensive Care Unit (ICU) admission Re-bleeding In-hospital mortality This composite definition was used to reflect clinically significant deterioration or the need for advanced care. | |
| Low risk upper gastrointestinal bleeding group | Patients who did not meet any of the above high-risk criteria during hospitalization were classified as low risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding.
The HOLD-B score (Hemoglobin, Lactate, Diastolic Blood Pressure, Blood Urea Nitrogen) is a risk stratification score developed in this study. The score ranges from 0 to 6, where higher scores indicate a higher probability of high-risk clinical outcomes.
Based on ROC analysis, the optimal cut-off value is 3.5.
High-risk upper gastrointestinal bleeding was defined as the occurrence of at least one of the following events during hospitalization:
blood transfusion
endoscopic hemostatic intervention
intensive care unit admission
rebleeding
in-hospital mortality
Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
Measured: 1 year
Secondary outcomes (1)
compare the effectiveness of the newly developed risk score
The predictive performance of the HOLD-B score will be compared with commonly used upper gastrointestinal bleeding risk scores, including:
Glasgow-Blatchford Score (GBS) Rockall Score Pre-endoscopic Rockall Score AIMS65 Score ABC Score (Age, blood tests, comorbidities) H3B2 Score (Hemodynamic Instability, Hemoglobin, Hematemesis, Blood Urea Nitrogen (BUN), Melena) ABL Score (systolic blood pressure, hemoglobin, BUN/Creatinine, INR/Albumin) Lactate/Hemoglobin Discriminative performance will be evaluated using ROC curve analysis, and AUC values will be compared using the DeLong test.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies 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
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ejder Saylav BORA, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458178
- Sponsor's protocol ID
- IZMIR-KCU-03
- Acronym
- UGIS
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guner NG, Catal F, Yurumez Y, Guneysu F, Bostanci F. Comparison of the new risk score (ABL) with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score in patients with upper gastrointestinal bleeding admitted to the emergency department. BMC Emerg Med. 2025 Jul 18;25(1):131. doi: 10.1186/s12873-025-01291-z.
PubMed 40681998
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding and Comparison of the Found Score With Scoring Systems in the Literature
- ClinicalTrials.gov ID
- NCT07458178
- Acronym / sponsor ID
- UGIS / IZMIR-KCU-03
- Keywords
- Upper Gastrointestinal Bleeding, risk scores, high risk bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Mar 2026 (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.
Upper gastrointestinal bleeding (UGIB) remains a common and potentially life-threatening emergency condition requiring early risk stratification to guide clinical management. Although several validated scoring systems such as Rockall, Glasgow-Blatchford Score (GBS), AIMS65, H3B2, ABC, ABL, and Pre-endoscopic Rockall (Pre-RS) are widely used, their discriminative performance for identifying patients at high clinical risk varies across populations.
This retrospective, single-center observational study included 312 adult patients admitted to the emergency department between January 2024 and January 2026 with clinical manifestations of UGIB. Patients were categorized into high-risk and low-risk groups based on clinically significant outcomes, including transfusion requirement, endoscopic/radiological/surgical intervention, intensive care unit admission, rebleeding, or in-hospital mortality.
The primary objective was to develop a novel risk score (HOLD_B), derived from independent predictors identified through multivariable logistic regression analysis. Receiver Operating Characteristic (ROC) curve analysis was used to determine optimal cut-off values for continuous predictors and to evaluate discriminative performance. The newly developed score was compared with established scoring systems using area under the curve (AUC) analysis and DeLong's test for pairwise comparisons.
The study aims to provide a simplified and clinically applicable risk stratification tool for early identification of high-risk UGIB patients in the emergency department setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| upper gastrointestinal bleeding | – | –clinical manifestations of upper gastrointestinal bleeding (UGIB) and subsequently hospitalized during |
| High-Risk upper gastrointestinal bleeding group | – | –Patients were classified as high risk if they met at least one of the following criteria during hospitalization: Requirement for blood transfusion Endoscopic hemostatic intervention Radiological intervention Surgical intervention Intensive Care Unit (ICU) admission Re-bleeding In-hospital mortality This composite definition was used to reflect clinically significant deterioration or the need for advanced care. |
| Low risk upper gastrointestinal bleeding group | – | –Patients who did not meet any of the above high-risk criteria during hospitalization were classified as low risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Demographic characteristics, presenting complaints, comorbid conditions, regularly used medications, mental status, vital signs, laboratory values, admission locations, blood transfusion requirements, endoscopic hemostasis procedures, radiological interventions, surgical procedures, length of stay (LOS), readmissions, and in-hospital mortality data were obtained from the electronic patient record system. All data were recorded by a single physician using a pre-prepared data collection form.
Key inclusion criteria (7 listed)
- Age ≥18 years
- Consecutive patients presenting to the emergency department between January 2024 and January 2026
- Clinical presentation suggestive of upper gastrointestinal bleeding, including hematemesis, melena, or hematochezia suspected to originate from the upper gastrointestinal tract due to rapid intestinal transit
- Patients who underwent upper gastrointestinal endoscopy during the index hospitalization
- Presence of endoscopic findings confirming upper gastrointestinal pathology
Key exclusion criteria (13 listed)
- Age <18 years
- Patients presenting with cardiac arrest at admission
- Intubated patients at the time of emergency department presentation
- Presence of concomitant active infectious diseases
- Patients diagnosed with esophageal variceal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding.
Time frame: 1 year
The HOLD-B score (Hemoglobin, Lactate, Diastolic Blood Pressure, Blood Urea Nitrogen) is a risk stratification score developed in this study. The score ranges from 0 to 6, where higher scores indicate a higher probability of high-risk clinical outcomes. Based on ROC analysis, the optimal cut-off value is 3.5. High-risk upper gastrointestinal bleeding was defined as the occurrence of at least one of the following events during hospitalization: blood transfusion endoscopic hemostatic intervention intensive care unit admission rebleeding in-hospital mortality Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
1 secondary outcome
compare the effectiveness of the newly developed risk score
Time frame: 1 year
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 13 Mar 2026.
- Results publication: PubMed 40681998Guner NG, Catal F, Yurumez Y, Guneysu F, Bostanci F. Comparison of the new risk score (ABL) with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score in patients with upper gastrointestinal bleeding admitted to the emergency department. BMC Emerg Med. 2025 Jul 18;25(1):131. doi: 10.1186/s12873-025-01291-z.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding (UGIB) and High Risk Bleeding, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 7 inclusion and 13 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458178, which also lists 1 linked publication.
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 13 Mar 2026.