PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding

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.

NCT Number	NCT06896409
Lead Sponsor	Tallaght University Hospital
Conditions	Upper Gastrointestinal Bleeding
Enrollment	126 participants
Start Date	2023-10-01
Primary Completion	2025-10 (estimated)
Study Completion	2025-10 (estimated)
Updated on ClinicalTrials.gov	2025-03-26