Upper GI BleedingNCT05876741
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 .
An observational study of Upper GI Bleeding, run by Sohag University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- history taking , vital signs and labaratory investigations
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 15 Mar 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
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: 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:
Who may be able to join
- 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.
Who cannot join
- · Patients less than 18 years.
- Missed follow-up.
Trial locations and contacts
1 site in 1 country.
Khairy H Morsy, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor, 0934602963, portal@med.sohag.edu.eg
Mera Fayez, Doctor, 01224890136, meraatef@med.sohag.edu.eg
About this study
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 .
Read more
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 .
- Conditions
- Upper GI Bleeding
- Being tested
- history taking , vital signs and labaratory investigations
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
history taking , vital signs and labaratory investigationsDiagnostic test
- 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 .
- Clinical examination: Pulse, blood pressure, calculating the shock index, pallor, jaundice, cachexia, purpura, ecchymosis, conscious level, abdominal examination.
- 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.
- Assessment of risk and predicting outcomes by:
- Pre-endoscopic Rockall score (pRS).
- Glasgow-Blatchford score (GBS).
- AIMS65 score.
- ABC score.
- Horibe score.
| Study group | Role | What they receive |
|---|---|---|
| Participants | patient presented with hematemesis , coffee ground vomiting , melena and haematoectasia to gastroenterology department will be included. Receives: Diagnostic Test: history taking , vital signs and labaratory investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between old and new upper git bleeding scoring systems regarding accuracy and prognostic value .
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.
Measured: 1 monthe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Feb 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
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 GI BleedingStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Aly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876741
- Sponsor's protocol ID
- Soh-Med-23-04-09MS
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horibe M, Iwasaki E, Bazerbachi F, Kaneko T, Matsuzaki J, Minami K, Masaoka T, Hosoe N, Ogura Y, Namiki S, Hosoda Y, Ogata H, Chan AT, Kanai T. Horibe GI bleeding prediction score: a simple score for triage decision-making in patients with suspected upper GI bleeding. Gastrointest Endosc. 2020 Sep;92(3):578-588.e4. doi: 10.1016/j.gie.2020.03.3846. Epub 2020 Mar 30.
PubMed 32240682Horibe M, Kaneko T, Yokogawa N, Yokota T, Okawa O, Nakatani Y, Ogura Y, Matsuzaki J, Iwasaki E, Hosoe N, Masaoka T, Inadomi JM, Suzuki H, Kanai T, Namiki S. A simple scoring system to assess the need for an endoscopic intervention in suspected upper gastrointestinal bleeding: A prospective cohort study. Dig Liver Dis. 2016 Oct;48(10):1180-6. doi: 10.1016/j.dld.2016.07.009. Epub 2016 Jul 18.
PubMed 27507771Kim MS, Choi J, Shin WC. AIMS65 scoring system is comparable to Glasgow-Blatchford score or Rockall score for prediction of clinical outcomes for non-variceal upper gastrointestinal bleeding. BMC Gastroenterol. 2019 Jul 26;19(1):136. doi: 10.1186/s12876-019-1051-8.
PubMed 31349816Laursen SB, Oakland K, Laine L, Bieber V, Marmo R, Redondo-Cerezo E, Dalton HR, Ngu J, Schultz M, Soncini M, Gralnek I, Jairath V, Murray IA, Stanley AJ. ABC score: a new risk score that accurately predicts mortality in acute upper and lower gastrointestinal bleeding: an international multicentre study. Gut. 2021 Apr;70(4):707-716. doi: 10.1136/gutjnl-2019-320002. Epub 2020 Jul 28.
PubMed 32723845