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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| Children's Medical Center Dallas | OTHER |
| University of Massachusetts, Worcester | OTHER |
| Children's Hospital of Philadelphia |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is an obsevational cohort study | Other | no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Management Strategies | Identify successful medical management strategies in pediatric patients diagnosed with acute upper gastrointestinal bleed | 3 years |
| Endoscopic Management Strategies |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael A Manfredi, MD | Contact | 617-355-6058 | michael.manfredi@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael A Manfredi, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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Identify successful endoscopic and medical interventions measured by incidence rate of re-bleeding
| 3 years |
| 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 |
| 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 |
| 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 |
| Boston Childrens Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |