Pediatric Acute Gastrointestinal Bleeding Registry (TRIAGE)

September 15, 2020 updated by: Michael A. Manfredi, MD, Boston Children's Hospital

Pediatric Acute Bleeding Registry: Identification of Clinical, Laboratory and Endoscopic Risk Factors Associated With Pediatric Upper Gastrointestinal Bleeding

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.

Study Overview

Detailed Description

A. Specific Aims/Objectives:

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.

B. Background and Significance:

Gastrointestinal (GI) hemorrhage is a potentially life-threatening presentation that the pediatric gastroenterologist must recognize, and manage appropriately. Classification is generally divided between upper or lower GI bleeding, based on the origin of bleeding relative to hemorrhages the Ligament of Treitz. The incidence of GI bleeding in children is not well established in the pediatric population. For upper GI bleeds most large, prospective studies have assessed incidence in pediatric critical care settings. In one prospective study of 984 patients, upper GI bleeds occurred in 6.4% of admissions receiving on prophylactic therapy. Other studies have shown upper GI bleeding in as many as 25% of pediatric intensive care admissions without prophylaxis. There is no data on the incidence of pediatric GI bleeds that requires endoscopic therapy.

Pediatric studies are lacking with respect to risk stratification and decisional algorithms in managing pediatric acute upper gastrointestinal bleeding. Adult literature supports accurate stratification of risk based on clinical history, physical examination, and laboratory measures. Additionally, endoscopic interventions not only allow for therapeutic interventions but also prognosticate based on visual findings. Similar pediatric literature is not available thus giving rise to large amounts of variability both center to center as well as within centers regarding management decision making.

C. Design and Methods:

  • Prospective, observational analysis of inpatient and ambulatory records of pediatric patients at Boston Children's Hospital beginning upon IRB approval.
  • We will identify pediatric patients </= 21 years old presenting acutely to the emergency room, ambulatory clinic or as current inpatients who require endoscopic evaluation for acute upper gastrointestinal bleed and potential treatment.
  • Data collected will include clinical signs and symptoms and physical exam features, laboratory studies and endoscopic findings
  • Identified patients will then be followed prospectively for outcomes data collection.
  • Data collection will include:

    • Clinical history of bleeding onset, acuity, amount, frequency and prior history of gastrointestinal bleed.
    • Medication history
    • Physical examination data including vital signs (heart rate, blood pressure, and oxygen saturation)
    • Laboratory data including
    • Complete blood count
    • Inflammatory markers (ESR and CRP)
    • Liver panel
    • Complete Metabolic Panel
    • Urinanalysis
    • Endoscopic findings as well as data from interventions (cautery, clips, injections)
    • Medical management decisions (acid suppression therapy, oral intake, frequency of laboratory measurement)
    • Outcome data including re-bleeding rates (with respect to endoscopic intervention), laboratory measures, and length of stay.

Study Type

Observational

Enrollment (Anticipated)

300

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

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
          • Lee Bass, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Childrens Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
          • Douglas Fishman, MD

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

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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 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
Develop a predictive/risk stratification algorithm for pediatric upper gastric intestinal bleeding
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Management Strategies
Time Frame: 3 years
Identify successful medical management strategies in pediatric patients diagnosed with acute upper gastrointestinal bleed
3 years
Endoscopic Management Strategies
Time Frame: 3 years
Identify successful endoscopic and medical interventions measured by incidence rate of re-bleeding
3 years
Re-Bleeding Risk Factors
Time Frame: 3 years
Identify pre-existing risk factors or clinical factors associated with re-bleeding rates following initial endoscopic or surgical intervention.
3 years
Identify Average length of Stay for Upper Gastrointestinal Bleeding
Time Frame: 3 years
Identify length of medical stabilization and/or observation prior to either endoscopic or surgical intervention measured in hours or days in medical supervision and subsequent outcome, incidence of re-bleeding,
3 years
Identify the incidence of significant upper gastrointestinal bleed in all pediatric hospital admission.
Time Frame: 3 years
Identify the incidence of significant upper gastrointestinal bleed in all pediatric hospital admission.
3 years

Collaborators and Investigators

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

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)

May 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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