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Pediatric Acute Gastrointestinal Bleeding Registry (TRIAGE)

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ClinicalTrials.gov Identifier: NCT03090945
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 6, 2018
Sponsor:
Collaborators:
Texas Children's Hospital
Children's Medical Center Dallas
University of Massachusetts, Worcester
Children's Hospital of Philadelphia
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Michael A. Manfredi, MD, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment
Upper Gastrointestinal Bleeding Gastro Intestinal Bleeding Other: This is an obsevational cohort study

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Pediatric Acute Bleeding Registry: Identification of Clinical, Laboratory and Endoscopic Risk Factors Associated With Pediatric Upper Gastrointestinal Bleeding
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: This is an obsevational cohort study
    no intervention


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Medical Management Strategies [ Time Frame: 3 years ]
    Identify successful medical management strategies in pediatric patients diagnosed with acute upper gastrointestinal bleed

  2. Endoscopic Management Strategies [ Time Frame: 3 years ]
    Identify successful endoscopic and medical interventions measured by incidence rate of re-bleeding

  3. 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.

  4. 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,

  5. 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090945


Contacts
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Contact: Michael A Manfredi, MD 617-355-6058 michael.manfredi@childrens.harvard.edu

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Lee Bass, MD         
United States, Massachusetts
Boston Childrens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael A Manfredi, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Douglas Fishman, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Texas Children's Hospital
Children's Medical Center Dallas
University of Massachusetts, Worcester
Children's Hospital of Philadelphia
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Michael A Manfredi, MD Boston Children’s Hospital

Additional Information:

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Responsible Party: Michael A. Manfredi, MD, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03090945     History of Changes
Other Study ID Numbers: P00021336
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael A. Manfredi, MD, Boston Children’s Hospital:
Endoscopy
GI Bleeding
Pediatrics
Upper Gastrointestinal Bleeding
Gastro Intestinal Bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases