Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,534

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach

2 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

October 24, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed

25 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

October 24, 2024

Last Update Submit

May 27, 2025

Conditions

AUGIB Gastrointestinal Bleeding

Keywords

AUGIBauditGreater Bay AreaGBAepidemiology

Outcome Measures

Primary Outcomes (1)

Mortality
Mortality of all causes
30 days

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

Patients younger than 18 years old.
Patients presenting with iron deﬁciency anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chinese University of Hong Konglead

Study Sites (40)

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Dongguan Songshan Lake Tungwah Hospital

Dongguan, Guangdong, China

Location

Donghua Hospital, Dongguan

Dongguan, Guangdong, China

Location

Houjie Hospital of Dongguan

Dongguan, Guangdong, China

Location

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 0000, China

Location

Guangzhou Red Cross Hospital