Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers
- Conditions
- Acute Gastrointestinal Bleeding
- Interventions
- Device: Conventional therapyDevice: UI-EWD
- Registration Number
- NCT06188585
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute overt gastrointestinal bleeding which is found at endoscopy to be due to a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel.
- Detailed Description
Endoscopic hemostatic therapy is recommended as the first line therapy for patients with upper gastrointestinal bleeding (UGIB) due to ulcers with active bleeding or a non-bleeding visible vessel identified at endoscopy. A variety of endoscopic modalities are used in the treatment of UGIB, including thermal therapies (e.g., bipolar electrocoagulation), injection therapy (e.g., epinephrine), clips, and hemostatic powder spray. Topical therapies, such as hemostatic powder spray, have been the most recent addition to the armamentarium of endoscopic therapies for UGIB.
UI-EWD hemostatic powder (Nexpowder™), which is manufactured by NextBiomedical and distributed by Medtronic, is approved for treatment of nonvariceal UGIB in the U.S., Canada, European Union and other countries.
A retrospective study of UI-EWD hemostatic powder in 56 patients with active bleeding found immediate hemostasis in 54 (96.4%), with rebleeding within 7 days in only 2 patients (3.7%)\[1\]. A large multi-center randomized trial in 340 patients with nonvariceal UGIB and either active bleeding or a non-bleeding visible vessel compared conventional endoscopic hemostatic therapy alone to conventional therapy plus UI-EWD. Rebleeding was significantly lower in the UI-EWD group at 3 days (3 vs. 11%) and at 30 days (19% vs. 7%) \[2\].
The primary aim of this trial is to demonstrate that UI-EWD when used as initial hemostatic therapy is non-inferior to older conventional endoscopic hemostatic therapy for the treatment of patients with high-risk peptic ulcer bleeding.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 278
- Adults age 22 years or older
- Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
- Subject voluntarily agrees to participate in the clinical investigation, provides written informed consent, and will be able to comply with the investigational protocol in the opinion of the site investigator
- Cause of bleeding as determined at endoscopy is gastric or duodenal ulcer bleeding with active spurting or oozing bleeding or a non-bleeding visible vessel. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic observation.
- Incarceration
- Subjects that are not able to provide written informed consent
- Subject already hospitalized for another condition when UGIB begins
- Pregnancy or nursing mothers
- Endoscopic hemostatic treatment in the past 30 days
- Use of triple antithrombotic therapy at the time of presentation
- Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
- Platelet count < 50 x 10^9/L
- INR > 3.5 (or prothrombin time >35 seconds in patient not on warfarin and only prothrombin time is provided by local lab), at time of procedure or closest to procedure time
- Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with documented hypersensitivity to Brilliant Blue FCF
- Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
- Endoscopy not performed within 30 hours of presentation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Conventional therapy Conventional endoscopic therapy Test Group UI-EWD UI-EWD
- Primary Outcome Measures
Name Time Method No further bleeding during the 7-day period after hemostatic treatment 7 days Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
- Secondary Outcome Measures
Name Time Method Number of participants with recurrent bleeding over the 7-day period after randomization 7 days Recurrent bleeding among all patients with hemostasis within 7 days after study-assigned endoscopic therapy
Mortality 30 days 30-day mortality
Composite 30-day outcome of further bleeding 30 days Further bleeding leading to red blood cell transfusion or urgent intervention (need for alternative therapy at index endoscopy, repeat endoscopy, interventional radiology, or surgery)
Number of participants with active bleeding (Forrest 1a/1b) at randomization who have initial hemostasis with study-assigned endoscopic therapy During index endoscopy procedure Initial hemostasis with study-assigned endoscopic therapy for patients with actively bleeding ulcers (Forrest Ia and Ib) at randomization
Trial Locations
- Locations (15)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Yale
🇺🇸New Haven, Connecticut, United States
RUSH University
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Rutgers University
🇺🇸Piscataway, New Jersey, United States
Northwell Health
🇺🇸Manhasset, New York, United States
NYU Langone
🇺🇸New York, New York, United States
McGill University
🇨🇦Montréal, Quebec, Canada
St. Michael's Hospital
🇨🇦Toronto, Canada
Vancouver General Hospital
🇨🇦Vancouver, Canada
Copenhagen University Hospital
🇩🇰Hvidovre, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
St. Antoine
🇫🇷Paris, France
Emek Medical Center
🇮🇱Afula, Israel
Cleveland Clinic London
🇬🇧London, United Kingdom