NCT03090945

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.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

5.8 years

First QC Date

March 20, 2017

Last Update Submit

September 15, 2020

Conditions

Upper Gastrointestinal BleedingGastro Intestinal Bleeding

Keywords

EndoscopyGI BleedingPediatricsUpper Gastrointestinal BleedingGastro Intestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Develop a predictive/risk stratification algorithm for pediatric upper gastric intestinal bleeding

    Identification of prognostic clinical history, physical examination, and laboratory measure risk factors that can predict/risk stratifies significant upper gastrointestinal bleeding in children.

    3 years

Secondary Outcomes (5)

  • Medical Management Strategies

    3 years

  • Endoscopic Management Strategies

    3 years

  • Re-Bleeding Risk Factors

    3 years

  • Identify Average length of Stay for Upper Gastrointestinal Bleeding

    3 years

  • Identify the incidence of significant upper gastrointestinal bleed in all pediatric hospital admission.

    3 years

Interventions

This is an obsevational cohort studyOTHER

no intervention

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All pediatric patients who present to the hospital or are currently hospitalized and presented with clinical signs of upper gastric intestinal bleeding that are severe enough that warrant the physician to perform an upper endoscopy.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Chicago, Illinois, 60611, United States

RECRUITING

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael A Manfredi, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Manfredi, MD

CONTACT

617-355-6058michael.manfredi@childrens.harvard.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 27, 2017

Study Start

May 1, 2017

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)