Clinical trial NCT05876741: 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 .
Official title: 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 .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper GI Bleeding
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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:

Brief 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 .

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: comparison between old and new upper git bleeding scoring systems regarding accuracy and prognostic value .
timeFrame: 1 monthe
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: 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.
citation: Horibe 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.
citation: Kim 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.
citation: Laursen 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.