Upper Gastrointestinal Bleeding (UGIB)NCT06878183
A New Risk Score for the Emergency Department in Patients With Upper Gastrointestinal Bleeding
An observational study of Upper Gastrointestinal Bleeding (UGIB) and Emergency Department Patient, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Background: The aim of this study was to develop a simpler, more practical, and highly effective risk scoring system for patients presenting to the emergency department with upper gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB), Emergency Department Patient, Risk Scores
- What is being tested?
- Routine laboratory tests of the patients were examined (such as hemogram, biochemistry, bleeding parameters).
- How many people
- 589 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged over 18 years who presented to the ED with UGIB symptoms and signs
Who may be able to join
- Patients aged over 18 years who presented to the ED with UGIB symptoms and signs (hematemesis, melena, and hematochezia) and were hospitalized between January 1, 2022, and June 1, 2023, were included in the study.
Who cannot join
- Patients with insufficient data, lower gastrointestinal bleeding, or those who did not undergo endoscopy due to death, refusal of treatment, or symptom resolution were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Sakarya, Adapazarı, 54100
About this study
Official title: Comparison of the New Risk Score (ABL Score) With the Glasgow Blatchford Score, AIMS65, and Pre-Endoscopic Rockall Score in Patients With Upper Gastrointestinal Bleeding Admitted to the Emergency Department
Abstract Background: The aim of this study was to develop a simpler, more practical, and highly effective risk scoring system for patients presenting to the emergency department with upper gastrointestinal bleeding.
Methods: This single-center retrospective observational study was conducted by reviewing data from patients aged 18 years and older who presented to the Emergency Medicine Clinic of Sakarya Training and Research Hospital with symptoms and signs of upper gastrointestinal bleeding between January, 2022 to June, 2023. Patients were divided into six groups for analysis. Patients included in the transfusion, intervention, intense care unit, readmission or mortality groups were classified as high risk. Using the obtained data, a new scoring system was developed, and its effectiveness in predicting high risk and all subgroups was compared with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score.
- Being tested
- Routine laboratory tests of the patients were examined (such as hemogram, biochemistry, bleeding parameters).
- Keywords
- Emergency department, Upper gastrointestinal bleeding, AIMS65, pre-RS, Glaskow Blatchfor Score, Risk score
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine laboratory tests of the patients were examined (such as hemogram, biochemistry, bleeding parameters).Other
Data obtained from routine examinations, laboratory tests and hospital reports were evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a new risk score capable of predicting the high-risk group
The primary outcome was to develop a new risk score that can predict the high-risk group in the emergency department in patients with upper gastrointestinal bleeding. In the new risk score, high scores were intended to be more associated with high risk.
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 posted14 Mar 2025
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necip Gökhan Güner, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878183
- Sponsor's protocol ID
- 43012747-050.04-438096
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meltzer AC, Burnett S, Pinchbeck C, Brown AL, Choudhri T, Yadav K, Fleischer DE, Pines JM. Pre-endoscopic Rockall and Blatchford scores to identify which emergency department patients with suspected gastrointestinal bleed do not need endoscopic hemostasis. J Emerg Med. 2013 Jun;44(6):1083-7. doi: 10.1016/j.jemermed.2012.11.021. Epub 2013 Jan 27.
PubMed 23360648Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
PubMed 21907980Ramaekers R, Mukarram M, Smith CA, Thiruganasambandamoorthy V. The Predictive Value of Preendoscopic Risk Scores to Predict Adverse Outcomes in Emergency Department Patients With Upper Gastrointestinal Bleeding: A Systematic Review. Acad Emerg Med. 2016 Nov;23(11):1218-1227. doi: 10.1111/acem.13101. Epub 2016 Nov 1.
PubMed 27640399Dicu D, Pop F, Ionescu D, Dicu T. Comparison of risk scoring systems in predicting clinical outcome at upper gastrointestinal bleeding patients in an emergency unit. Am J Emerg Med. 2013 Jan;31(1):94-9. doi: 10.1016/j.ajem.2012.06.009. Epub 2012 Sep 20.
PubMed 23000328
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the New Risk Score (ABL Score) With the Glasgow Blatchford Score, AIMS65, and Pre-Endoscopic Rockall Score in Patients With Upper Gastrointestinal Bleeding Admitted to the Emergency Department
- ClinicalTrials.gov ID
- NCT06878183
- Acronym / sponsor ID
- 43012747-050.04-438096
- Keywords
- Emergency department, Upper gastrointestinal bleeding, AIMS65, pre-RS, Glaskow Blatchfor Score, Risk score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 14 Mar 2025 (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.
Abstract Background: The aim of this study was to develop a simpler, more practical, and highly effective risk scoring system for patients presenting to the emergency department with upper gastrointestinal bleeding.
Methods: This single-center retrospective observational study was conducted by reviewing data from patients aged 18 years and older who presented to the Emergency Medicine Clinic of Sakarya Training and Research Hospital with symptoms and signs of upper gastrointestinal bleeding between January, 2022 to June, 2023. Patients were divided into six groups for analysis. Patients included in the transfusion, intervention, intense care unit, readmission or mortality groups were classified as high risk. Using the obtained data, a new scoring system was developed, and its effectiveness in predicting high risk and all subgroups was compared with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 years who presented to the ED with UGIB symptoms and signs
Key inclusion criteria (1 listed)
- Patients aged over 18 years who presented to the ED with UGIB symptoms and signs (hematemesis, melena, and hematochezia) and were hospitalized between January 1, 2022, and June 1, 2023, were included in the study.
Key exclusion criteria (1 listed)
- Patients with insufficient data, lower gastrointestinal bleeding, or those who did not undergo endoscopy due to death, refusal of treatment, or symptom resolution were excluded.
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 |
|---|---|---|
| Routine laboratory tests of the patients were examined (such as hemogram, biochemistry, bleeding parameters).Data obtained from routine examinations, laboratory tests and hospital reports were evaluated. | Other | – |
Primary outcome
Develop a new risk score capable of predicting the high-risk group
Time frame: 1 year
The primary outcome was to develop a new risk score that can predict the high-risk group in the emergency department in patients with upper gastrointestinal bleeding. In the new risk score, high scores were intended to be more associated with high risk.
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 Mar 2025.
- Results publication: PubMed 23360648Meltzer AC, Burnett S, Pinchbeck C, Brown AL, Choudhri T, Yadav K, Fleischer DE, Pines JM. Pre-endoscopic Rockall and Blatchford scores to identify which emergency department patients with suspected gastrointestinal bleed do not need endoscopic hemostasis. J Emerg Med. 2013 Jun;44(6):1083-7. doi: 10.1016/j.jemermed.2012.11.021. Epub 2013 Jan 27.
- Results publication: PubMed 21907980Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
- Results publication: PubMed 27640399Ramaekers R, Mukarram M, Smith CA, Thiruganasambandamoorthy V. The Predictive Value of Preendoscopic Risk Scores to Predict Adverse Outcomes in Emergency Department Patients With Upper Gastrointestinal Bleeding: A Systematic Review. Acad Emerg Med. 2016 Nov;23(11):1218-1227. doi: 10.1111/acem.13101. Epub 2016 Nov 1.
- Results publication: PubMed 23000328Dicu D, Pop F, Ionescu D, Dicu T. Comparison of risk scoring systems in predicting clinical outcome at upper gastrointestinal bleeding patients in an emergency unit. Am J Emerg Med. 2013 Jan;31(1):94-9. doi: 10.1016/j.ajem.2012.06.009. Epub 2012 Sep 20.
- 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 Emergency Department Patient, run by Sakarya 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 1 inclusion and 1 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 Mar 2025. 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?
Develop a new risk score capable of predicting the high-risk group (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 NCT06878183, which also lists 4 linked publications.
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 Mar 2025.