Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trimebutine Maleate, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleeding, Gastrointestinal Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Trimebutine Maleate in Enhancing Endoscopic Gastric Visualization in Patients With Acute Upper Gastrointestinal Bleeding: A Double-Blind Randomized Controlled Trial
Overview
Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures. This study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose. Researchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols. The primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).
Interventions
- Drug Trimebutine Maleate
50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy. - Other Placebo
A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
Primary outcome measures
- Total Gastric Visualization Score [Time frame: 60 to 90 minutes post-intervention]
Secondary outcome measures (1)
- Identification Rate of Bleeding Source [Time frame: 60 to 90 minutes post-intervention]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena.
- Planned urgent upper gastrointestinal endoscopy within 24 hours.
Exclusion criteria
- Known gastric outlet obstruction.
- Previous gastric surgery.
- Pregnancy or lactation.
- Allergy to Trimebutine Maleate.
- Chronic use of prokinetic medications.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07749300 · Trimebutine for UGIB Endoscopy