Acute Gastrointestinal Bleeding
Conditions
Keywords
Gastrointestinal hemorrhage, Peptic Ulcer, Nonvariceal upper gastrointestinal bleeding
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 one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear.
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 GI bleeding 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 nonvariceal upper GI bleeding.
Interventions
DEVICEUI-EWD
Hemostatic powder administered at index endoscopy
DEVICEConventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
Sponsors
Medtronic - MITG
North American Science Associates Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned with concealed allocation in a 1:1 ratio to receive treatment with UI-EWD hemostatic powder (Nexpowder) or conventional endoscopic hemostatic therapy (defined as bipolar electrocoagulation or clips or argon plasma coagulation with or without epinephrine injection therapy).
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults age 22 years or older 2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia) 3. 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 4. Cause of bleeding as determined at upper endoscopy is one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic observation.
Exclusion criteria
1. Incarceration 2. Subjects that are not able to provide written informed consent 3. Pregnancy or nursing mothers 4. Endoscopic hemostatic treatment in the past 30 days 5. Use of triple antithrombotic therapy at the time of presentation 6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months 7. Post-polypectomy bleeding 8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia 9. Platelet count \< 50 x 10\^9/L 10. 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 11. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 12. Subjects with documented hypersensitivity to Brilliant Blue FCF 13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation. 14. Endoscopy not performed within 36 hours of presentation to hospital/emergency department
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Initial hemostasis for patients with active bleeding at randomization | During index endoscopy procedure | Initial hemostasis with study-assigned endoscopic therapy for patients with active bleeding |
| 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 |
Countries
Canada, Denmark, France, Israel, United Kingdom, United States
Contacts
CONTACTGeraldine Kelly
CONTACTKara Saddoris
STUDY_CHAIRLoren Laine, MD
Yale University
Outcome results
None listed