Validation of Prognostic Accuracy of ABC ( Age, Blood Urea Nitrogen , Co-morbidities ) and Horibe Pre-endoscopy Scoring Systems in Patients With Upper Gastrointestinal Bleeding in Sohag University Hospital .

May 17, 2023 updated by: Mohamed Ahmed Aly, Sohag University

Upper gastrointestinal bleeding (UGIB) is a common medical emergency with significant morbidity and mortality. Treating physicians are urged to perform rapid diagnosis, careful risk assessment, and effective resuscitation to improve outcomes and limit the risk of complications .

Several prognostic scoring systems have been developed to identify high- and low-risk patients presenting with UGIB and are commonly used in emergency departments to classify patients. Identifying low-risk patients who can be treated electively or on an outpatient basis can reduce the burden on physicians, patients, and the healthcare system (Rout et al., 2019). On the other hand, identifying high-risk patients who require immediate hospitalization and intervention can help avoid delays in treatment, thereby reducing morbidity and mortality. By using appropriate risk assessment tools, it is possible not only to predict which patients are at risk of adverse events such as rebleeding or death, but also to make management decisions such as the timing of endoscopy, length of hospital stay, and level of care .

Several pre-endoscopy scoring systems have been developed to predict the need for hospital-based intervention (transfusion, endoscopic treatment, radiological embolization, or surgery) and 30-day mortality risk. The pre-endoscopic Rockall score (pRS), the Glasgow-Blatchford score (GBS), and the AIMS65 score are the most widely used scoring systems in clinical practice .

The GBS was established as a tool for assessing the need for medical interventions (e.g., blood transfusion, therapeutic endoscopy, or surgery). The pRS and AIMS65 have been shown to predict mortality most accurately among patients with UGIB. In addition, AIMS65 is a simple risk score consisting of easily accessible parameters that was created to improve adherence to risk stratification and facilitate early triage and targeted therapy. However, there are limitations in these scoring systems. The GBS is difficult to calculate in routine clinical practice due to its complex nature . Moreover, the discriminative performance of existing scores for the prediction of mortality is relatively poor .

Two new relatively simple scores were developed to predict the outcome in patients presenting with UGIB, the Horibe gastrointestinal bleeding (HARBINGER) score (Horibe et al., 2016), and the Age, Blood tests, and Comorbidities (ABC) score (Laursen et al., 2021). The Horibe score was developed primarily to triage patients presented with UGIB (need for hospital admission, endoscopic intervention), while the ABC score was developed to predict 30-day mortality in patients presenting with UGIB. Both scores demonstrated good performance in studies conducted for their validation and may be superior to the existing pre-endoscopy scores .

Study Overview

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Khairy H Morsy, Professor
  • Phone Number: 20 114 329 2343

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients presented to the outpatient clinic, emergency or inpatient section of the Tropical Medicine and Gastroenterology Department, Sohag University Hospital by UGIB as defined by haematemesis (vomiting of blood or coffee ground emesis), or melena will be included in the study.

Exclusion Criteria:

Description

Inclusion Criteria:

  • All patients presented to the outpatient clinic, emergency or inpatient section of the Tropical Medicine and Gastroenterology Department, Sohag University Hospital by UGIB as defined by haematemesis (vomiting of blood or coffee ground emesis), or melena will be included in the study.

Exclusion Criteria:

  • · Patients less than 18 years.

    • Missed follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
patient presented with hematemesis , coffee ground vomiting , melena and haematoectasia to gastroenterology department will be included.
  1. Complete history taking:

    With stress on age, sex, epigastric pain, comorbidities (ischemic heart disease, diabetes, liver cirrhosis, renal failure, malignancy), syncope, disturbed conscious level, blood transfusion, drug history .

  2. Clinical examination:

    Pulse, blood pressure, calculating the shock index, pallor, jaundice, cachexia, purpura, ecchymosis, conscious level, abdominal examination.

  3. Laboratory investigations:

    • Complete blood count (CBC).
    • Creatinine and blood urea nitrogen (BUN).
    • liver function tests (serum bilirubin, serum albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin time (PT), prothrombin concentration (PC), and international normalized ratio (INR)).
    • Serum electrolytes and arterial blood gases.
    • Fasting blood sugar.
  4. Assessment of risk and predicting outcomes by:

    • Pre-endoscopic Rockall score (pRS).
    • Glasgow-Blatchford score (GBS).
    • AIMS65 score.
    • ABC score.
    • Horibe score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between old and new upper git bleeding scoring systems regarding accuracy and prognostic value .
Time Frame: 1 monthe
As UGIB is a medical emergency requiring timely decisions, physicians must know exactly which risk scores are reliable for each clinical outcome. The currently existing scores are either difficult to calculate or not accurate at predicting the outcome for which they developed. Two new scores (the Horibe and the ABC) were developed to overcome the drawbacks of the existing scores, So, we conducted the current study to validate them.
1 monthe

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Estimated)

February 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-23-04-09MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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