NCT06878183

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

February 27, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Emergency departmentUpper gastrointestinal bleedingAIMS65pre-RSGlaskow Blatchfor ScoreRisk score

Outcome Measures

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.

    1 year

Interventions

Data obtained from routine examinations, laboratory tests and hospital reports were evaluated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 23360648BACKGROUND
  • 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.

    PMID: 21907980BACKGROUND
  • 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.

    PMID: 27640399BACKGROUND
  • 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.

    PMID: 23000328BACKGROUND

MeSH Terms

Conditions

Gastrointestinal HemorrhageEmergencies

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 14, 2025

Study Start

January 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations