PuraStat® Combined With Adrenaline Versus Standard of Care in Non-variceal Upper Gastrointestinal Bleeding. Multicentric International Clinical Trial.

Endoscopic treatment serves as the first-line approach in managing upper gastrointestinal bleeding (UGIB), demonstrating effectiveness in reducing re-bleeding rates, the need for surgical intervention, and mortality. In non-variceal UGIB, endoscopic management includes various techniques such as injection therapy, thermal therapy, mechanical therapy, or a combination, depending on the lesion type. However, certain factors, including the anatomical location of the lesion, underlying fibrosis, or diffuse bleeding, can present challenges to successful treatment.

Haemostatic powders have been increasingly utilized as both primary and salvage therapy for bleeding control in various clinical scenarios, including post-polypectomy bleeding, bleeding associated with colonic tumors, diverticula, arteriovenous malformations, radiation proctitis, ischemic colitis, and surgical intestinal anastomoses. Their use in UGIB management has also expanded. Compared to other modalities, these topical agents offer advantages such as ease of application, the ability to reach lesions in challenging locations, and coverage of larger surface areas without requiring precise targeting.

Among the most extensively studied topical hemostatic agents are TC-325 (Hemospray®, Cook Medical), the Polysaccharide Hemostatic System (Endoclot® PHS), and Inha University-Endoscopic Wound Dressing (UI-EWD) (NextBiomedical Co., Incheon, South Korea). These agents have demonstrated high rates of immediate haemostasis (86%-100%) when used alone or in combination with other haemostatic methods, exhibiting excellent feasibility and a favorable safety profile.

The primary limitation of these agents is their adherence exclusively to actively bleeding sites, leading to rapid washout within 12-24 hours, thereby making them a temporary measure. Additionally, their opacity obscures the underlying mucosa after application, preventing further visualization of the lesion during the procedure. Further studies are required to better define the role of hemostatic powders, establish optimal use settings, and evaluate long-term efficacy and safety in bleeding control.

PuraStat® is a novel gel that provides 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. The pre-filled syringe design facilitates ease of handling and precise delivery.