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Completed

NCT Number: NCT07819942

Comparison of Risk Scores in Upper Gastrointestinal Bleeding

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kathmandu Medical College and Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

About this study

Upper gastrointestinal bleeding (UGIB) is a common medical emergency associated with significant morbidity and mortality. Early risk stratification is essential to guide timely intervention, prioritize endoscopy, optimize resource allocation, and identify low risk patients suitable for conservative or outpatient management. Several pre-endoscopic scoring systems, including the Glasgow-Blatchford Score (GBS), AIMS65, and the pre endoscopic Rockall Score, are commonly used; however, their their comparative performance varies across populations, and local data from Nepal remain limited.

This prospective observational study aims to compare the predictive accuracy of GBS, AIMS65, and pre-endoscopic Rockall Score in patients presenting with upper gastrointestinal bleeding at a tertiary care hospital in Nepal over a six-month study period. The primary outcomes will include in-hospital mortality and need for clinical intervention (blood transfusion, endoscopic therapy, surgery, or ICU admission). Secondary outcomes will include rebleeding and length of hospital stay. Predictive performance will be evaluated using receiver operating characteristic curve analysis.

The findings of this study are expected to identify the most appropriate pre-endoscopic risk stratification tool for UGIB in the Nepalese context, thereby supporting early clinical decision-making and improving patient management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Requirement for Blood Transfusion Within 24 Hours

    Time frame: Within 24 hours of hospital admission

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

  2. Rate of Intensive Care Unit (ICU) Admission

    Time frame: through study completion, an average of 7 days

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

Secondary outcomes

  1. In-Hospital Rebleeding Rate

    Time frame: through study completion, an average of 7 days

    Proportion of participants experiencing recurrent bleeding (characterized by fresh hematemesis, melena with hemodynamic instability, or persistent drop in hemoglobin (>2gm/dl) after index hemostasis during the index admission.

  2. Early Mortality (Within 48 Hours)

    Time frame: Within 48 hours of hospital admission.

    Proportion of all-cause patient deaths occurring within 48 hours of initial presentation.

  3. Overall In-Hospital Mortality

    Time frame: through study completion, an average of 7 days

    Proportion of all-cause patient deaths occurring during the index hospital stay.

Sponsors and collaborators

Lead sponsor

Kathmandu Medical College and Teaching Hospital

Other

Registry information

Official study title

Comparison of the Glasgow Blatchford Score, AIMS65, and Pre Endoscopic Rockall Score in Predicting Outcomes of Upper Gastrointestinal Bleeding at a Tertiary Care Centre

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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