Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03374800 · ClinicalTrials.gov registry record · Phase 3
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
A Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper), sponsored by McMaster University.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,800
- Enrollment target
- 20
- Study locations
NCT03374800: Completed Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper), sponsored by McMaster University.
NCT03374800 is a Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper) that has completed, run by McMaster University. The registered enrollment target is 4,800 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03374800, a Phase 3 study of Gastrointestinal Hemorrhage (Clinically Important, Upper), has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,800 participants
- Enrollment target
- 20
- Study locations
Study Summary
Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to decades ago, critically ill patients rarely develop upper gastrointestinal bleeding. This decrease is likely due to modern medicine, better resuscitation and earlier feeding. There may also be harms associated with pantoprazole and other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and bowel infections (Clostridioides difficile). Studies in this area are old and of modest quality. Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems. The goal of this international study is to determine if, in critically ill patients using breathing machines, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia) and bowel infection (Clostridioides difficile), or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.
Primary Outcome
Clinically important upper GI bleeding requires the presence of overt GI bleeding which is defined as one of the following; * Hematemesis * Overt nasogastric bleeding * Melena * Hematochezia PLUS (in the absence of another cause), at least one of the following in the 24 hours following overt GI bleeding: * Haemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of 20 mmHg or more or an orthostati
Conditions Studied
Interventions
- DRUG Placebo (0.9% saline)
- DRUG Pantoprazole
Study Locations (20)
New South Wales
- Bankstown-Lidcombe Hospital - Bankstown
- Blacktown Hospital - Blacktown
- Sutherland Hospital - Caringbah
- Gosford Hospital - Gosford
- Nepean Hospital - Kingswood
- St George Hospital - Kogarah
- Royal North Shore Hospital - Saint Leonards
- Wollongong Hospital - Wollongong
Victoria
- Bendigo Health - Bendigo
- Geelong University Hospital - Geelong
- Austin Hospital - Heidelberg
- Alfred Hospital - Melbourne
- Royal Melbourne Hospital - Melbourne
- Epworth Hospital - Melbourne
Queensland
- Royal Brisbane Womens Hospital - Brisbane
- Ipswich Hospital - Ipswich
- Mater Hospital - South Brisbane
- Princess Alexandra Hospital - Woolloongabba
Nebraska
- University of Nebraska - Nebraska Medical Center - Omaha
South Australia
- Royal Adelaide Hospital - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,800 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 3 |
What the finished NCT03374800 record still lists
NCT03374800 is an interventional study that assigns participants to a tested intervention. Its 4,800 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher).
The record links to 1 condition, with Gastrointestinal Hemorrhage (Clinically Important, Upper) appearing as the primary indexed condition, and to 2 interventions - of which Placebo (0.9% saline) is the first listed.
NCT03374800 names 20 study sites across 5 states, led by New South Wales, Victoria, Queensland.
Frequently Asked Questions
What is clinical trial NCT03374800 about?
NCT03374800 is a clinical study titled "Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial". Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, t...
What is the current status of trial NCT03374800?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,800 participants. The study started on 2018-07-09. Estimated completion is 2024-01-31.
What conditions does trial NCT03374800 study?
This clinical trial studies the following conditions: Gastrointestinal Hemorrhage (Clinically Important, Upper).
What interventions are being tested in trial NCT03374800?
The interventions under investigation include: Placebo (0.9% saline) (DRUG), Pantoprazole (DRUG).
Who is sponsoring clinical trial NCT03374800?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03374800 being conducted?
This trial has 20 study locations across Nebraska, New South Wales, Queensland, South Australia, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03374800's enrollment target sits among peer trials
4,800 53rd of 2000 higher than 1,947 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01719055 · 4,800 participants
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- NCT05485675 · 4,800 participants · NA
Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program
- NCT06307652 · 4,800 participants · Phase 3
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
- NCT05252754 · 4,874 participants · Phase 3
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI