Pediatric Acute Gastrointestinal Bleeding Registry

NCT ID: NCT03090945

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2023-12-01

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.

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.

Conditions

Upper Gastrointestinal Bleeding; Gastro Intestinal Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

This is an obsevational cohort study

no intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Children's Medical Center Dallas

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael A. Manfredi, MD

Assistant Professor of Pediatrics, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Manfredi, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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

Chicago, Illinois, United States

Site Status: RECRUITING

Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael A Manfredi, MD

Role: CONTACT

michael.manfredi@childrens.harvard.edu

617-355-6058

Facility Contacts

Lee Bass, MD

Role: primary

Michael A Manfredi, MD

Role: primary

Douglas Fishman, MD

Role: primary

Other Identifiers

P00021336

Identifier Type: -

Identifier Source: org_study_id