- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090945
Pediatric Acute Gastrointestinal Bleeding Registry (TRIAGE)
Pediatric Acute Bleeding Registry: Identification of Clinical, Laboratory and Endoscopic Risk Factors Associated With Pediatric Upper Gastrointestinal Bleeding
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michael A Manfredi, MD
- Phone Number: 617-355-6058
- Email: michael.manfredi@childrens.harvard.edu
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A Manfredi, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00021336
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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