Acute Non-variceal Upper Gastrointestinal BleedingNCT06697691
Clinical Prediction Model for In-Hospital Rebleeding in Acute Non-Variceal Upper Gastrointestinal Bleeding
An observational study of Acute Non-variceal Upper Gastrointestinal Bleeding, run by Junwei Yan at 1 site in China.
Trial summary
ANVUGIB is a serious condition that can cause symptoms like vomiting blood or passing black stools. Although treatments have improved, about 10% to 30% of patients experience rebleeding shortly after their initial treatment, which increases the risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Non-variceal Upper Gastrointestinal Bleeding
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2024to Dec 2024
- Phase
- Observational
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: The study population consisted of patients hospitalized for AUGIB at the Central Hospital of Wuhan from December 2021 to December 2023
Who may be able to join
- age exceeding 18 years,
- Clinical diagnosis of Acute Non-Variceal Upper Gastrointestinal Bleeding ,
- patients who underwent endoscopy within 24 hours of admission with confirmation of non-variceal bleeding
Who cannot join
- Upper Gastrointestinal Bleeding during hospitalization;
- transfer from other hospitals;
- variceal bleeding;
- lower gastrointestinal bleeding.;
- bleeding attributed to systemic diseases like disseminated intravascular coagulation (DIC) and hematological disorders;
- patients with incomplete clinical data or laboratory test results;
- patients who either requested early discharge or declined gastroscopy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Central Hospital of Wuhan
Wuhan, Hubei, 430000
heng zhang, 653262549@qq.com
About this study
Official title: Construction of a Clinical Prediction Model for In-Hospital Rebleeding in Patients With Acute Non-Venous Upper Gastrointestinal Bleeding
ANVUGIB is a serious condition that can cause symptoms like vomiting blood or passing black stools. Although treatments have improved, about 10% to 30% of patients experience rebleeding shortly after their initial treatment, which increases the risk of death.
Currently, doctors use tools like the Glasgow-Blatchford Score, Rockall Score, and AIM65 Score to predict how patients with ANVUGIB might recover. However, these tools are not very effective at identifying patients who are at risk for rebleeding. This study aims to create a new, more accurate prediction model to help doctors identify high-risk patients earlier. The investigators believe that a new predictive model, which combines patient symptoms, lab test results, and imaging findings, will improve the ability to identify patients at high risk of rebleeding compared to existing tools.The goal is to provide doctors with a more reliable tool to guide their decisions, such as when to give preventive treatments or increase monitoring. This could lead to better outcomes and reduce the risk of complications or death.
This study uses patient data collected during routine care to develop and test the new model, ensuring the findings are directly applicable to real-world clinical settings.
- Keywords
- rebleeding, acute non-variceal upper gastrointestinal bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
relbeeding
Rebleeding was defined as hematemesis, hematochezia, and/or melena within 7 days of the initial bleeding, accompanied by hemodynamic instability or a decrease in hemoglobin of at least 2 g/dl within 24 hours.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start22 Nov 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Non-variceal Upper Gastrointestinal BleedingStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junwei Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junwei Yan, Wuhan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697691
- Sponsor's protocol ID
- ANVUGIB-2024-001
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided