Clinical Prediction Model for In-Hospital Rebleeding in Acute Non-Variceal Upper Gastrointestinal Bleeding

November 25, 2024 updated by: Junwei Yan

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consisted of patients hospitalized for AUGIB at the Central Hospital of Wuhan from December 2021 to December 2023

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relbeeding
Time Frame: up to 7 days
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.
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junwei Yan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANVUGIB-2024-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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