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CompletedNCT06878183Updated Mar 14, 2025

A New Risk Score for the Emergency Department in Patients with Upper Gastrointestinal Bleeding

An observational study in Upper Gastrointestinal Bleeding (UGIB), Emergency Department Patient and Risk Scores, sponsored by Sakarya University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Sakarya University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
589
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Upper Gastrointestinal Bleeding (UGIB)
  • Emergency Department Patient
  • Risk Scores

Keywords

  • Emergency department
  • Upper gastrointestinal bleeding
  • AIMS65
  • pre-RS
  • Glaskow Blatchfor Score
  • Risk score
03

In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's enrollment of 589 is above the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients aged over 18 years who presented to the ED with UGIB symptoms and signs

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
589 participants (actual)
Patient registry
No

Interventions

  • OtherRoutine 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 site
  • Sakarya Training and Research Hospital
    Sakarya, Adapazarı 54100, Turkey
08

References and documents

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 23360648 ↗
  • Saltzman 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 21907980 ↗
  • Ramaekers 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 27640399 ↗
  • Dicu 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06878183
Lead sponsor
Sakarya University
Responsible party
Necip Gökhan Güner (Assistant Professor, MD, Sakarya University) — Principal investigator
First posted
Mar 14, 2025
Start date
Jan 1, 2022
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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