Pediatric Acute Gastrointestinal Bleeding Registry

Upper Gastrointestinal Bleeding Clinical Trial

— TRIAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090945
• Other study ID #: P00021336
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2020
• Source: Boston Children's Hospital
• Contact: Michael A Manfredi, MD
• Phone: 617-355-6058
• Email: michael.manfredi[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Other:
• This is an obsevational cohort study
no intervention

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Texas Children's Hospital	Houston	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Boston Children's Hospital	Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Children's Hospital of Philadelphia, Children's Medical Center Dallas, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medical Management Strategies	Identify successful medical management strategies in pediatric patients diagnosed with acute upper gastrointestinal bleed	3 years
Secondary	Endoscopic Management Strategies	Identify successful endoscopic and medical interventions measured by incidence rate of re-bleeding	3 years
Secondary	Re-Bleeding Risk Factors	Identify pre-existing risk factors or clinical factors associated with re-bleeding rates following initial endoscopic or surgical intervention.	3 years
Secondary	Identify Average length of Stay for Upper Gastrointestinal Bleeding	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
Secondary	Identify the incidence of significant upper gastrointestinal bleed in all pediatric hospital admission.	Identify the incidence of significant upper gastrointestinal bleed in all pediatric hospital admission.	3 years