Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2023-05-20
2024-06-30
Brief Summary
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Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?
Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Metoclopramide
Given 10 mg Metoclopramide prior to Endoscopy
Metoclopramide 10mg
IV Metoclopramide
Placebo
Given saline flush prior to Endoscopy
Saline
Placebo
Interventions
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Metoclopramide 10mg
IV Metoclopramide
Saline
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside
* Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena
* Plan to undergo EGD within 24 hours since admission or since first symptoms
* Calculated Glasgow-Blatchford score ≥ 2
Exclusion Criteria
* Known allergy to metoclopramide
* Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome
* History of TD or dystonic reaction to metoclopramide
* Pheochromocytoma, catecholamine-releasing paragangliomas
* Parkinson's Disease
* Epilepsy
* Pregnancy or lactation
* Previous gastrectomy
18 Years
ALL
Yes
Sponsors
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Mercy Health System
NETWORK
Responsible Party
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Mudassar Sandozi
Principal Investigator
Locations
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Javon Bea Hospital-Riverside - MercyHealth
Rockford, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Altaf Dawood
Role: primary
References
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Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011.
Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31.
Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available.
Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.
Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.
Other Identifiers
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#323
Identifier Type: -
Identifier Source: org_study_id
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