Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT03090945

Conditions

Upper Gastrointestinal Bleeding

Gastro Intestinal Bleeding

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

This is an obsevational cohort study

Study Details

Brief summary:

The goal of this study is to identify significant clinical and laboratory risk factors in pediatric patients with significant upper gastrointestinal bleeding. This is defined as bleeding that necessitates an upper endoscopic evaluation to either diagnose or treat upper GI bleeding during their hospital admission. If a predictive/risk stratification relationship exists, these data could permit a more effective triaging and intervention scheme in pediatric patients presenting with complaints of gastrointestinal bleeding. In addition we want to get a better understanding of the re-bleeding rate after endoscopic therapy for upper GI bleeding and if there are any identifiable risk factors for re-bleeding. Lastly we want to understand best practice management for upper GI bleeding.

Conditions

Upper Gastrointestinal Bleeding

Gastro Intestinal Bleeding

Study ID

NCT03090945

Start date

May 1, 2017

Status verified date

Sep, 2020

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Mar 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All pediatric patients will selected based on signs and symptoms of upper gastrointestinal bleeding and their need to have an upper endoscopy performed.

Exclusion Criteria:

  • None

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

This is an obsevational cohort study

no intervention

Primary outcome measure

  • Develop a predictive/risk stratification algorithm for pediatric upper gastric intestinal bleeding [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Boston Children's Hospital

Last update posted

Sep 16, 2020

Last verified

Sep, 2020

Keywords

  • Endoscopy
  • GI Bleeding
  • Pediatrics
  • Upper Gastrointestinal Bleeding
  • Gastro Intestinal Bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2020-09-16.