Actively Recruiting
PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding
Led by Tallaght University Hospital · Updated on 2025-03-26
126
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PuraStat® is a novel gel that offers several advantages over traditional hemostatic powders. Its transparency allows for continuous visualization of the bleeding site, and it can be applied in narrow spaces or in combination with other treatments. Additionally, the pre-filled syringe design ensures ease of handling and precise delivery. Most published data on PuraStat® as a hemostatic agent originates from surgical settings. In endoscopy, its primary applications have been in polypectomy-related hemostasis and the promotion of wound healing. Reports indicate a hemostasis success rate of 90.4%, with a recurrence rate of 10.4%. Limited data exist regarding the efficacy of PuraStat® as a hemostatic agent in upper gastrointestinal bleeding (UGIB) lesions. This study hypothesizes that PuraStat®, when combined with Adrenaline, serves as a feasible and effective first-line treatment for gastrointestinal bleeding. To evaluate this, a prospective, randomized, parallel-group, open-label clinical trial is proposed.
CONDITIONS
Official Title
PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding
You will not qualify if you...
- Variceal or portal hypertension-related gastrointestinal bleeding
- Lack of signed consent form
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Arnau de Vilanova de Lleida
Lleida, Spain
Actively Recruiting
Research Team
R
Raquel Ballester
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here