NCT05457062

Brief Summary

This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 13, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

July 9, 2022

Last Update Submit

July 9, 2022

Conditions

Upper GI Bleeding

Outcome Measures

Primary Outcomes (1)

  • death in hospital

    all cause death in hospital

    6 weeks

Secondary Outcomes (1)

  • rebleeding

    5 days

Study Arms (3)

large amount of bleeding

large amount of upper GI bleeding after EGD identified

no bleeding

no upper GI bleeding after EGD identified

small amount of bleeding

small amount of upper GI bleeding after EGD identified

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

upper GI bleeding patients who will under go endoscopy examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhalation

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Qian Bi, phD

CONTACT

66933216381021791@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2022

First Posted

July 13, 2022

Study Start

July 4, 2022

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

July 13, 2022

Record last verified: 2022-06

Locations

CN(1)