Comparison of Risk Scores in Upper Gastrointestinal Bleeding

NCT07819942 | Completed

• 1 other identifier: UGIBleed_KMCTH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is to compare the Glasgow-Blatchford Score (GBS), AIMS65, and pre-endoscopic Rockall Score in predicting outcomes among patients with upper gastrointestinal bleeding (UGIB). The main questions it aims to answer are: Which score best predicts in-hospital mortality and need for clinical intervention? Which score best predicts rebleeding and length of hospital stay? Researchers will compare the predictive performance of the three scoring systems. Participants will have their clinical and laboratory data collected and will be followed during their hospital stay for relevant outcomes.

Conditions

UGI Bleed

Keywords

Gastrointestinal Hemorrhage; Risk Assessment; Prognosis; Decision Support Techniques

Outcome Measures

Primary Outcomes (2)

• Requirement for Blood Transfusion Within 24 Hours

  Proportion of participants requiring blood transfusion (packed red blood cells or Whole blood) within 24 hours of presentation.

  Within 24 hours of hospital admission

• Rate of Intensive Care Unit (ICU) Admission

  Proportion of participants requiring admission to the ICU due to severe upper gastrointestinal bleeding or hemodynamic instability.

  through study completion, an average of 7 days

Secondary Outcomes (3)

• In-Hospital Rebleeding Rate

  through study completion, an average of 7 days

• Early Mortality (Within 48 Hours)

  Within 48 hours of hospital admission.

• Overall In-Hospital Mortality

  through study completion, an average of 7 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients (≥16 years) presenting with signs and symptoms of acute upper gastrointestinal bleeding- hematemesis, melena, or hematochezia-at the Emergency Department or Gastroenterology Unit.

You may qualify if:

• Age ≥16 years.
• Presenting with acute UGIB (hematemesis, melena, or hematochezia).
• Patients providing informed written consent.

You may not qualify if:

• Patients with lower gastrointestinal bleeding or uncertain source of bleeding.
• Patients with prior UGIB within the last 30 days.
• Patients refusing consent.
• Patients who are lost to follow-up before assessment of primary outcomes.

Sponsors & Collaborators

• Kathmandu Medical College and Teaching Hospital: lead

Study Sites (1)

Kathmandu Medical College and Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (8)

• Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316.

  PMID: 8675081 BACKGROUND

• Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.

  PMID: 33929377 BACKGROUND

• 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: 27640399 BACKGROUND

• Bou Daher H, Gregoski MJ, Rockey DC. Risk scoring systems to predict in-hospital mortality in patients with cirrhosis admitted with acute upper gastrointestinal bleeding. J Investig Med. 2026 Apr;74(3):260-268. doi: 10.1177/10815589251357622. Epub 2025 Jun 30.

  PMID: 40586355 BACKGROUND

• Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21. doi: 10.1016/S0140-6736(00)02816-6.

  PMID: 11073021 BACKGROUND

• 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: 23360648 BACKGROUND

• Wilkins T, Wheeler B, Carpenter M. Upper Gastrointestinal Bleeding in Adults: Evaluation and Management. Am Fam Physician. 2020 Mar 1;101(5):294-300.

  PMID: 32109037 BACKGROUND

• Saydam SS, Molnar M, Vora P. The global epidemiology of upper and lower gastrointestinal bleeding in general population: A systematic review. World J Gastrointest Surg. 2023 Apr 27;15(4):723-739. doi: 10.4240/wjgs.v15.i4.723.

  PMID: 37206079 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 15, 2026
• Study Start: February 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting information will be available from February 2026 to July 2026. IPD and supporting information will be available beginning 6 months after the publication of results and will be accessible for 2 years.
• Access Criteria: Access to the IPD and supporting information will be available to researchers who provide a research plan and have the necessary ethical approvals. Researchers can request access via email request to the corresponding author. The data will be provided in a secure format to ensure confidentiality and appropriate use. Additionally, the journal will provide access to the data as part of the publication process, in line with their data sharing policies, once the study results are published

Locations

NE (1)