AUGIBAUGIB AuditNCT06659783
The First Acute Upper Gastrointestinal Bleeding (AUGIB) Audit in the Greater Bay Area (GBA) of China
An observational study of AUGIB and Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 40 sites in 2 countries.
Trial summary
Investigators aim to conduct a large-scale, prospective cohort study in the Greater Bay Area of South China. Investigators aim to identify consecutive patients with AUGIB in the area over a 2-month period in the second quarter of 2025. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AUGIB, Gastrointestinal Bleeding
- How many people
- 4,534 participants
- Where
- 40 sitesin 2 countries
- Study dates
- 20 Nov 2024to 19 Feb 2025
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons.
Who may be able to join
- Patients would be included in the study if they are aged 18 years or older and have clinical evidence of AUGIB on admission, or clinical evidence of AUGIB while as an inpatient for any other reason. We also include patients with hematochezia as some patients with brisk AUGIB can present rectal bleeding
Who cannot join
- Patients younger than 18 years old.
- Patients presenting with iron deficiency anemia.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
China39 sites
Dongguan People's Hospital
Dongguan, Guangdong
Dongguan Songshan Lake Tungwah Hospital
Dongguan, Guangdong
Donghua Hospital, Dongguan
Dongguan, Guangdong
Houjie Hospital of Dongguan
Dongguan, Guangdong
Guangzhou First People's Hospital
Guangdong, Guangzhou, 123
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 0000
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 123
Huadu District People's Hospital
Guangzhou, Guangdong, 123
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 123
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, 123
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 123
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 123
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Huizhou Central People's Hospital
Huizhou, Guangdong
Huizhou First People's Hospital
Huizhou, Guangdong
Jiangmen Central Hospital
Jiangmen, Guangdong
Wuyi Hospital of Traditional Chinese Medicine
Jiangmen, Guangdong
Kiang Wu Hospital
Macao, Macao, 123
Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)
Shenzhen, Guangdong, 123
Shenzhen People's Hospital
Shenzhen, Guangdong, 123
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 123
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong
Longgang District People's Hospital, Shenzhen (The Second Affiliated Hospital of The Chinese University of Hong Kong, Shenzhen)
Shenzhen, Guangdong
Longhua New District People's Hospital, Shenzhen
Shenzhen, Guangdong
Southern Medical University Shenzhen Hospital
Shenzhen, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital
Zhaoqing, Guangdong
Zhaoqing First People's Hospital
Zhaoqing, Guangdong
Huoju Development District Hospital
Zhongshan, Guangdong
Zhongshan People's Hospital
Zhongshan, Guangdong
Foshan First People's Hospital
Zhuhai, Guangdong
Foshan Second People's Hospital
Zhuhai, Guangdong
Southern Medical University Shunde Hospital
Zhuhai, Guangdong
The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai - Foshan City (3 Centers)
Zhuhai, Guangdong
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Investigators aim to conduct a large-scale, prospective cohort study in the Greater Bay Area of South China. Investigators aim to identify consecutive patients with AUGIB in the area over a 2-month period in the second quarter of 2025.
This study covers the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) as well as the western, eastern, and northern regions of Guangdong Province. It comprises of 2 Special Administrative Regions of Hong Kong and Macao and 21 municipalities in Guangdong Province (Guangzhou, Shenzhen, Foshan, Dongguan, Zhongshan, Zhuhai, Jiangmen, Zhaoqing, Huizhou, Shantou, Chaozhou, Jieyang, Shanwei, Zhanjiang, Maoming, Yangjiang, Yunfu, Shaoguan, Qingyuan, Meizhou, Heyuan). The total population of the Guangdong-Hong Kong-Macao area is estimated to be 135.24 million. Investigators aim to understand the current epidemiology of AUGIB in South China by collecting patient characteristics, the care model and management strategies including the use of endoscopy, interventional radiology and surgery, and the associated mortality.
Read more
The goal is to identify areas for improving patients' outcomes and to reduce mortality. The audit also provides a reference standard for future audits and a comparison to a minimal international standard.
Acute Upper gastrointestinal bleeding (AUGIB) remains a common medical emergency. Although the annual incidence of AUGIB has decreased from approximately 100 per 100,000 adults in the 1990s to 61-78 per 100,000 persons in 2009-2012, the 30-day mortality rate remains as high as 11%. The overall etiology and epidemiology of acute UGIB have undergone significant changes. The widespread eradication of H. pylori, the use of safer non-steroidal anti-inflammatory drugs (NSAIDs), and the use of proton pump inhibitors (PPIs) have reduced the incidence of bleeding peptic ulcers. The increasing prevalence of alcohol-related liver disease, common usage of anticoagulant or antiplatelet therapy, and an aging population (with associated co-morbidities) often worsen the prognosis. Overall, in the management of patients with AUGIB, the diagnostic and treatment methods such as endoscopic hemostasis have improved. This together with better access to both high-dependency care and interventional radiology can all contribute to better patient outcome in acute UGIB.
Epidemiologic studies in acute upper gastrointestinal hemorrhage from Asia mostly come from hospital-based studies with limited number of cases. These studies are largely retrospective in their nature. In China, there is a lack of population-based studies on AUGIB. There are also uncertainties in how these patients are managed especially over adoption of risk stratification tools, timely provision of care, the use of endoscopic hemostatic treatment, the use of drugs and red cell transfusion, and interventional radiology.
To understand the current epidemiology of AUGIB in the GBA, investigators aim to conduct a large-scale, prospective cohort study in the Greater Bay Area of South China. In this audit, Investigators identify patients with AUGIB admitted to participating hospitals and collect their demographic data, clinical presentation, management and outcomes The goal is to identify areas of opportunities in reducing mortality and improving patient outcomes.
This is a population based, unselected multicentre, prospective survey. Consecutive patients who present with signs of AUGIB, aged >18, admitted to the participating hospitals from August 1, 2024, to September 30, 2024, are identified. These patients include those admitted through the emergency department, and clinics, and patients who develop bleeding while being hospitalized for other reasons.
Read the detailed description
Up to forty hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025 are identified. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons At each center a "lead" consultant is designated to represent the hospital on the project. Lead PI and designated research staff identify cases by screening admission records to accident and emergency department and the admission wards, records in the endoscopy centre, interventional radiology suites and operating theater, and through direct communication with admitting staff at respective clinical area. To ensure completeness of case ascertainment, an audit coordinator will cross check data entry against hospital admission, discharge records including records of the deceased. For each identified, the site PI and designated research staff will extract relevant data to complete an audit questionnaire and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. All records are anonymized. The following information is being collected. A central audit coordinator checks at weekly interval completeness of questionnaire entry and communicate with site research staff for clarification.
Information extracted included demographics, clinical history (such as admission date, time, clinical areas , referral pattern, past medical history, signs and symptoms at presentation, observations at time of presentation for the clinical episode), laboratory tests, medications, interventions and clinical outcomes
Acute upper gastrointestinal bleeding is defined as the passage of melaena and/or firm clinical evidence and laboratory support for acute blood loss from the upper gastrointestinal (UGI) tract.
This is an observational study. All patients are managed per each center's standard of care. Therefore, no extra intervention is administered and thus there would be no adverse effects expected from the present study. In each enrolled centre, a "lead" consultant together with designated research staff including at least a medical doctor and an audit coordinator will make sure all data are collected correctly and faithfully. The lead investigator of the study will be in direct contact with each centre for any problem related to the study.
This is an observational study. All patients are managed and followed up per each center's standard of care. Therefore, no extra intervention is administered.
Data are presented as percentages with numerator/denominator and as summary statistics of median and inter-quartile ranges (IQR) or mean (standard deviation) as appropriate. Binary regression methods are used to calculate risk ratios and 95% confidence intervals to assess the association of clinical factors with outcomes (inpatient mortality, re-bleeding, red blood cell transfusion). Risk ratios for the type of admission, co-morbidities, and alcohol abuse were computed after adjusting for patient age, which was categorized into quintiles.
At each center a "lead" consultant is designated to represent the hospital on the project. Lead PI and designated research staff identify cases by screening admission records to accident and emergency department and the admission wards, records in the endoscopy centre, interventional radiology suites and operating theater, and through direct communication with admitting staff at respective clinical area. To ensure completeness of case ascertainment, an audit coordinator will cross check data entry against hospital admission, discharge records including records of the deceased. For each identified, the site PI and designated research staff will extract relevant data to complete an audit questionnaire and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. All records are anonymized. The following information is being collected. A central audit coordinator checks at weekly interval completeness of questionnaire entry and communicate with site research staff for clarification.
Information extracted included demographics, clinical history (such as admission date, time, clinical areas , referral pattern, past medical history, signs and symptoms at presentation, observations at time of presentation for the clinical episode), laboratory tests, medications, interventions and clinical outcomes
Acute upper gastrointestinal bleeding is defined as the passage of melaena and/or firm clinical evidence and laboratory support for acute blood loss from the upper gastrointestinal (UGI) tract.
This is an observational study. All patients are managed per each center's standard of care. Therefore, no extra intervention is administered and thus there would be no adverse effects expected from the present study. In each enrolled centre, a "lead" consultant together with designated research staff including at least a medical doctor and an audit coordinator will make sure all data are collected correctly and faithfully. The lead investigator of the study will be in direct contact with each centre for any problem related to the study.
This is an observational study. All patients are managed and followed up per each center's standard of care. Therefore, no extra intervention is administered.
Data are presented as percentages with numerator/denominator and as summary statistics of median and inter-quartile ranges (IQR) or mean (standard deviation) as appropriate. Binary regression methods are used to calculate risk ratios and 95% confidence intervals to assess the association of clinical factors with outcomes (inpatient mortality, re-bleeding, red blood cell transfusion). Risk ratios for the type of admission, co-morbidities, and alcohol abuse were computed after adjusting for patient age, which was categorized into quintiles.
For each included case, the audit coordinator will extract relevant data to complete the audit questionnaires and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. Data will be electronically exported from the website into SPSS. Any duplicate cases will be identified and removed from the dataset prior to analysis. Dates (e.g., date of admission, date of endoscopy, date of discharge) will be verified, and free-text comments regarding presentation and diagnoses were reclassified where possible. Clinical leads will be contacted for clarification when necessary.
- Conditions
- AUGIB, Gastrointestinal Bleeding
- Keywords
- AUGIB, audit, Greater Bay Area, GBA, epidemiology
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unselected acute UGIB adult patients admitted with overt signs of AUGIB or in-bleeder | 40 hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025 are identified. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality of all causes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start20 Nov 2024
- Primary completion19 Jan 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AUGIBStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 4,534 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, MD, Chinese University of Hong Kong
- Investigators
- Side Liu, PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659783
- Sponsor's protocol ID
- AUGIB Audit GBA
- Acronym
- AUGIB Audit
- Status last verified
- May 2025
- First submitted
- 24 Oct 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laine L, Spiegel B, Rostom A, Moayyedi P, Kuipers EJ, Bardou M, Sung J, Barkun AN. Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference. Am J Gastroenterol. 2010 Mar;105(3):540-50. doi: 10.1038/ajg.2009.702. Epub 2009 Dec 22.
PubMed 20029415Siau K, Hearnshaw S, Stanley AJ, Estcourt L, Rasheed A, Walden A, Thoufeeq M, Donnelly M, Drummond R, Veitch AM, Ishaq S, Morris AJ. British Society of Gastroenterology (BSG)-led multisociety consensus care bundle for the early clinical management of acute upper gastrointestinal bleeding. Frontline Gastroenterol. 2020 Mar 27;11(4):311-323. doi: 10.1136/flgastro-2019-101395. eCollection 2020.
PubMed 32582423Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
PubMed 21490373Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.
PubMed 31634917Wuerth BA, Rockey DC. Changing Epidemiology of Upper Gastrointestinal Hemorrhage in the Last Decade: A Nationwide Analysis. Dig Dis Sci. 2018 May;63(5):1286-1293. doi: 10.1007/s10620-017-4882-6. Epub 2017 Dec 27.
PubMed 29282637Laine L, Yang H, Chang SC, Datto C. Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009. Am J Gastroenterol. 2012 Aug;107(8):1190-5; quiz 1196. doi: 10.1038/ajg.2012.168. Epub 2012 Jun 12.
PubMed 22688850Abougergi MS, Travis AC, Saltzman JR. The in-hospital mortality rate for upper GI hemorrhage has decreased over 2 decades in the United States: a nationwide analysis. Gastrointest Endosc. 2015 Apr;81(4):882-8.e1. doi: 10.1016/j.gie.2014.09.027. Epub 2014 Dec 5.
PubMed 25484324Sung JJ, Chiu PW, Chan FKL, Lau JY, Goh KL, Ho LH, Jung HY, Sollano JD, Gotoda T, Reddy N, Singh R, Sugano K, Wu KC, Wu CY, Bjorkman DJ, Jensen DM, Kuipers EJ, Lanas A. Asia-Pacific working group consensus on non-variceal upper gastrointestinal bleeding: an update 2018. Gut. 2018 Oct;67(10):1757-1768. doi: 10.1136/gutjnl-2018-316276. Epub 2018 Apr 24.
PubMed 29691276Kwan I, Bunn F, Chinnock P, Roberts I. Timing and volume of fluid administration for patients with bleeding. Cochrane Database Syst Rev. 2014 Mar 5;2014(3):CD002245. doi: 10.1002/14651858.CD002245.pub2.
PubMed 24599652Rosenstock SJ, Moller MH, Larsson H, Johnsen SP, Madsen AH, Bendix J, Adamsen S, Jensen AG, Zimmermann-Nielsen E, Nielsen AS, Kallehave F, Oxholm D, Skarbye M, Jolving LR, Jorgensen HS, Schaffalitzky de Muckadell OB, Thomsen RW. Improving quality of care in peptic ulcer bleeding: nationwide cohort study of 13,498 consecutive patients in the Danish Clinical Register of Emergency Surgery. Am J Gastroenterol. 2013 Sep;108(9):1449-57. doi: 10.1038/ajg.2013.162. Epub 2013 Jun 4.
PubMed 23732464
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Acute Upper Gastrointestinal Bleeding (AUGIB) Audit in the Greater Bay Area (GBA) of China
- ClinicalTrials.gov ID
- NCT06659783
- Acronym / sponsor ID
- AUGIB Audit / AUGIB Audit GBA
- Conditions
- AUGIB, Gastrointestinal Bleeding
- Keywords
- AUGIB, audit, Greater Bay Area, GBA, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,534 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 26 Oct 2024 (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.
Investigators aim to conduct a large-scale, prospective cohort study in the Greater Bay Area of South China. Investigators aim to identify consecutive patients with AUGIB in the area over a 2-month period in the second quarter of 2025.
This study covers the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) as well as the western, eastern, and northern regions of Guangdong Province. It comprises of 2 Special Administrative Regions of Hong Kong and Macao and 21 municipalities in Guangdong Province (Guangzhou, Shenzhen, Foshan, Dongguan, Zhongshan, Zhuhai, Jiangmen, Zhaoqing, Huizhou, Shantou, Chaozhou, Jieyang, Shanwei, Zhanjiang, Maoming, Yangjiang, Yunfu, Shaoguan, Qingyuan, Meizhou, Heyuan). The total population of the Guangdong-Hong Kong-Macao area is estimated to be 135.24 million. Investigators aim to understand the current epidemiology of AUGIB in South China by collecting patient characteristics, the care model and management strategies including the use of endoscopy, interventional radiology and surgery, and the associated mortality.
The goal is to identify areas for improving patients' outcomes and to reduce mortality. The audit also provides a reference standard for future audits and a comparison to a minimal international standard.
Acute Upper gastrointestinal bleeding (AUGIB) remains a common medical emergency. Although the annual incidence of AUGIB has decreased from approximately 100 per 100,000 adults in the 1990s to 61-78 per 100,000 persons in 2009-2012, the 30-day mortality rate remains as high as 11%. The overall etiology and epidemiology of acute UGIB have undergone significant changes. The widespread eradication of H. pylori, the use of safer non-steroidal anti-inflammatory drugs (NSAIDs), and the use of proton pump inhibitors (PPIs) have reduced the incidence of bleeding peptic ulcers. The increasing prevalence of alcohol-related liver disease, common usage of anticoagulant or antiplatelet therapy, and an aging population (with associated co-morbidities) often worsen the prognosis. Overall, in the management of patients with AUGIB, the diagnostic and treatment methods such as endoscopic hemostasis have improved. This together with better access to both high-dependency care and interventional radiology can all contribute to better patient outcome in acute UGIB.
Epidemiologic studies in acute upper gastrointestinal hemorrhage from Asia mostly come from hospital-based studies with limited number of cases. These studies are largely retrospective in their nature. In China, there is a lack of population-based studies on AUGIB. There are also uncertainties in how these patients are managed especially over adoption of risk stratification tools, timely provision of care, the use of endoscopic hemostatic treatment, the use of drugs and red cell transfusion, and interventional radiology.
To understand the current epidemiology of AUGIB in the GBA, investigators aim to conduct a large-scale, prospective cohort study in the Greater Bay Area of South China. In this audit, Investigators identify patients with AUGIB admitted to participating hospitals and collect their demographic data, clinical presentation, management and outcomes The goal is to identify areas of opportunities in reducing mortality and improving patient outcomes.
This is a population based, unselected multicentre, prospective survey. Consecutive patients who present with signs of AUGIB, aged >18, admitted to the participating hospitals from August 1, 2024, to September 30, 2024, are identified. These patients include those admitted through the emergency department, and clinics, and patients who develop bleeding while being hospitalized for other reasons.
Detailed description
Up to forty hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025 are identified. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons At each center a "lead" consultant is designated to represent the hospital on the project. Lead PI and designated research staff identify cases by screening admission records to accident and emergency department and the admission wards, records in the endoscopy centre, interventional radiology suites and operating theater, and through direct communication with admitting staff at respective clinical area. To ensure completeness of case ascertainment, an audit coordinator will cross check data entry against hospital admission, discharge records including records of the deceased. For each identified, the site PI and designated research staff will extract relevant data to complete an audit questionnaire and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. All records are anonymized. The following information is being collected. A central audit coordinator checks at weekly interval completeness of questionnaire entry and communicate with site research staff for clarification.
Information extracted included demographics, clinical history (such as admission date, time, clinical areas , referral pattern, past medical history, signs and symptoms at presentation, observations at time of presentation for the clinical episode), laboratory tests, medications, interventions and clinical outcomes
Acute upper gastrointestinal bleeding is defined as the passage of melaena and/or firm clinical evidence and laboratory support for acute blood loss from the upper gastrointestinal (UGI) tract.
This is an observational study. All patients are managed per each center's standard of care. Therefore, no extra intervention is administered and thus there would be no adverse effects expected from the present study. In each enrolled centre, a "lead" consultant together with designated research staff including at least a medical doctor and an audit coordinator will make sure all data are collected correctly and faithfully. The lead investigator of the study will be in direct contact with each centre for any problem related to the study.
This is an observational study. All patients are managed and followed up per each center's standard of care. Therefore, no extra intervention is administered.
Data are presented as percentages with numerator/denominator and as summary statistics of median and inter-quartile ranges (IQR) or mean (standard deviation) as appropriate. Binary regression methods are used to calculate risk ratios and 95% confidence intervals to assess the association of clinical factors with outcomes (inpatient mortality, re-bleeding, red blood cell transfusion). Risk ratios for the type of admission, co-morbidities, and alcohol abuse were computed after adjusting for patient age, which was categorized into quintiles.
At each center a "lead" consultant is designated to represent the hospital on the project. Lead PI and designated research staff identify cases by screening admission records to accident and emergency department and the admission wards, records in the endoscopy centre, interventional radiology suites and operating theater, and through direct communication with admitting staff at respective clinical area. To ensure completeness of case ascertainment, an audit coordinator will cross check data entry against hospital admission, discharge records including records of the deceased. For each identified, the site PI and designated research staff will extract relevant data to complete an audit questionnaire and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. All records are anonymized. The following information is being collected. A central audit coordinator checks at weekly interval completeness of questionnaire entry and communicate with site research staff for clarification.
Information extracted included demographics, clinical history (such as admission date, time, clinical areas , referral pattern, past medical history, signs and symptoms at presentation, observations at time of presentation for the clinical episode), laboratory tests, medications, interventions and clinical outcomes
Acute upper gastrointestinal bleeding is defined as the passage of melaena and/or firm clinical evidence and laboratory support for acute blood loss from the upper gastrointestinal (UGI) tract.
This is an observational study. All patients are managed per each center's standard of care. Therefore, no extra intervention is administered and thus there would be no adverse effects expected from the present study. In each enrolled centre, a "lead" consultant together with designated research staff including at least a medical doctor and an audit coordinator will make sure all data are collected correctly and faithfully. The lead investigator of the study will be in direct contact with each centre for any problem related to the study.
This is an observational study. All patients are managed and followed up per each center's standard of care. Therefore, no extra intervention is administered.
Data are presented as percentages with numerator/denominator and as summary statistics of median and inter-quartile ranges (IQR) or mean (standard deviation) as appropriate. Binary regression methods are used to calculate risk ratios and 95% confidence intervals to assess the association of clinical factors with outcomes (inpatient mortality, re-bleeding, red blood cell transfusion). Risk ratios for the type of admission, co-morbidities, and alcohol abuse were computed after adjusting for patient age, which was categorized into quintiles.
For each included case, the audit coordinator will extract relevant data to complete the audit questionnaires and enter the data into a secure web-based Case Report Form, which can only be accessed using a unique hospital identifier and password. Data will be electronically exported from the website into SPSS. Any duplicate cases will be identified and removed from the dataset prior to analysis. Dates (e.g., date of admission, date of endoscopy, date of discharge) will be verified, and free-text comments regarding presentation and diagnoses were reclassified where possible. Clinical leads will be contacted for clarification when necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unselected acute UGIB adult patients admitted with overt signs of AUGIB or in-bleeder | – | –40 hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025 are identified. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 hospitals receiving emergency admissions in the Guangdong-Hong Kong-Macao area in China are invited to participate in this study. Unselected acute UGIB adult patients (≥18 years old) admitted within a 2-month period in the second quarter of 2025. These patients are newly admitted patients from both the emergency department and clinics with overt signs of AUGIB, as well as patients who develop bleeding while hospitalized for other reasons.
Key inclusion criteria (1 listed)
- Patients would be included in the study if they are aged 18 years or older and have clinical evidence of AUGIB on admission, or clinical evidence of AUGIB while as an inpatient for any other reason. We also include patients with hematochezia as some patients with brisk AUGIB can present rectal bleeding
Key exclusion criteria (2 listed)
- Patients younger than 18 years old.
- Patients presenting with iron deficiency anemia.
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
Mortality
Time frame: 30 days
Mortality of all causes
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 31 May 2025.
- Results publication: PubMed 20029415Laine L, Spiegel B, Rostom A, Moayyedi P, Kuipers EJ, Bardou M, Sung J, Barkun AN. Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference. Am J Gastroenterol. 2010 Mar;105(3):540-50. doi: 10.1038/ajg.2009.702. Epub 2009 Dec 22.
- Results publication: PubMed 32582423Siau K, Hearnshaw S, Stanley AJ, Estcourt L, Rasheed A, Walden A, Thoufeeq M, Donnelly M, Drummond R, Veitch AM, Ishaq S, Morris AJ. British Society of Gastroenterology (BSG)-led multisociety consensus care bundle for the early clinical management of acute upper gastrointestinal bleeding. Frontline Gastroenterol. 2020 Mar 27;11(4):311-323. doi: 10.1136/flgastro-2019-101395. eCollection 2020.
- Results publication: PubMed 21490373Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
- Results publication: PubMed 31634917Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.
- Results publication: PubMed 29282637Wuerth BA, Rockey DC. Changing Epidemiology of Upper Gastrointestinal Hemorrhage in the Last Decade: A Nationwide Analysis. Dig Dis Sci. 2018 May;63(5):1286-1293. doi: 10.1007/s10620-017-4882-6. Epub 2017 Dec 27.
- Results publication: PubMed 22688850Laine L, Yang H, Chang SC, Datto C. Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009. Am J Gastroenterol. 2012 Aug;107(8):1190-5; quiz 1196. doi: 10.1038/ajg.2012.168. Epub 2012 Jun 12.
- Results publication: PubMed 25484324Abougergi MS, Travis AC, Saltzman JR. The in-hospital mortality rate for upper GI hemorrhage has decreased over 2 decades in the United States: a nationwide analysis. Gastrointest Endosc. 2015 Apr;81(4):882-8.e1. doi: 10.1016/j.gie.2014.09.027. Epub 2014 Dec 5.
- Results publication: PubMed 29691276Sung JJ, Chiu PW, Chan FKL, Lau JY, Goh KL, Ho LH, Jung HY, Sollano JD, Gotoda T, Reddy N, Singh R, Sugano K, Wu KC, Wu CY, Bjorkman DJ, Jensen DM, Kuipers EJ, Lanas A. Asia-Pacific working group consensus on non-variceal upper gastrointestinal bleeding: an update 2018. Gut. 2018 Oct;67(10):1757-1768. doi: 10.1136/gutjnl-2018-316276. Epub 2018 Apr 24.
- Results publication: PubMed 24599652Kwan I, Bunn F, Chinnock P, Roberts I. Timing and volume of fluid administration for patients with bleeding. Cochrane Database Syst Rev. 2014 Mar 5;2014(3):CD002245. doi: 10.1002/14651858.CD002245.pub2.
- Results publication: PubMed 23732464Rosenstock SJ, Moller MH, Larsson H, Johnsen SP, Madsen AH, Bendix J, Adamsen S, Jensen AG, Zimmermann-Nielsen E, Nielsen AS, Kallehave F, Oxholm D, Skarbye M, Jolving LR, Jorgensen HS, Schaffalitzky de Muckadell OB, Thomsen RW. Improving quality of care in peptic ulcer bleeding: nationwide cohort study of 13,498 consecutive patients in the Danish Clinical Register of Emergency Surgery. Am J Gastroenterol. 2013 Sep;108(9):1449-57. doi: 10.1038/ajg.2013.162. Epub 2013 Jun 4.
- Individual participant dataSharing planned: Undecided
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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.
Side Liu, PhD principal investigator
Nanfang Hospital, Southern Medical University
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AUGIB and Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 40 sites in 2 countries.
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 1 inclusion and 2 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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in China, Hong Kong. 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?
Mortality (time frame: 30 days). 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 NCT06659783, which also lists 10 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 31 May 2025.