UGI BleedNCT07819942
Comparison of Risk Scores in Upper Gastrointestinal Bleeding
An observational study of UGI Bleed, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- UGI Bleed
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age ≥16 years.
- Presenting with acute UGIB (hematemesis, melena, or hematochezia).
- Patients providing informed written consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Kathmandu Medical College and Teaching Hospital
Kathmandu, Bagmati, 44600
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- UGI Bleed
- Keywords
- Gastrointestinal Hemorrhage, Risk Assessment, Prognosis, Decision Support Techniques
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 7 days
Secondary outcomes (3)
In-Hospital Rebleeding Rate
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.
Measured: through study completion, an average of 7 days
Early Mortality (Within 48 Hours)
Proportion of all-cause patient deaths occurring within 48 hours of initial presentation.
Measured: Within 48 hours of hospital admission.
Overall In-Hospital Mortality
Proportion of all-cause patient deaths occurring during the index hospital stay.
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UGI BleedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajwol Neupane, Kathmandu Medical College and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819942
- Sponsor's protocol ID
- UGIBleed_KMCTH
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) to be shared will include all anonymized data relevant to the study, such as demographic information (age, gender, etc.), clinical outcomes, laboratory values, and any other study-specific variables that may have been collected. The IPD will be anonymized to ensure patient confidentiality and in compliance with ethical standards for data privacy.
Publications
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.
PubMed 8675081Laine 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.
PubMed 33929377Ramaekers 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.
PubMed 27640399Bou 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.
PubMed 40586355Blatchford 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.
PubMed 11073021Meltzer 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.
PubMed 23360648Wilkins T, Wheeler B, Carpenter M. Upper Gastrointestinal Bleeding in Adults: Evaluation and Management. Am Fam Physician. 2020 Mar 1;101(5):294-300.
PubMed 32109037Saydam 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.
PubMed 37206079
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07819942
- Acronym / sponsor ID
- UGIBleed_KMCTH
- Conditions
- UGI Bleed
- Keywords
- Gastrointestinal Hemorrhage, Risk Assessment, Prognosis, Decision Support Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kathmandu Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥16 years.
- Presenting with acute UGIB (hematemesis, melena, or hematochezia).
- Patients providing informed written consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
In-Hospital Rebleeding Rate
Time frame: through study completion, an average of 7 days
Early Mortality (Within 48 Hours)
Time frame: Within 48 hours of hospital admission.
Overall In-Hospital Mortality
Time frame: through study completion, an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 8675081Rockall 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.
- Background: PubMed 33929377Laine 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.
- Background: PubMed 27640399Ramaekers 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.
- Background: PubMed 40586355Bou 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.
- Background: PubMed 11073021Blatchford 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.
- Background: PubMed 23360648Meltzer 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.
- Background: PubMed 32109037Wilkins T, Wheeler B, Carpenter M. Upper Gastrointestinal Bleeding in Adults: Evaluation and Management. Am Fam Physician. 2020 Mar 1;101(5):294-300.
- Background: PubMed 37206079Saydam 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.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) to be shared will include all anonymized data relevant to the study, such as demographic information (age, gender, etc.), clinical outcomes, laboratory values, and any other study-specific variables that may have been collected. The IPD will be anonymized to ensure patient confidentiality and in compliance with ethical standards for data privacy.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of UGI Bleed, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement for Blood Transfusion Within 24 Hours (time frame: Within 24 hours of hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819942, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.