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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTallaght University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age >18 years

Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding

Disqualifiers

Variceal or portal hypertension-related gastrointestinal bleeding

Lack of signed consent form

Pregnancy or breastfeeding

Trial design

Treatments tested in this trial

  • PuraStat® combined with Adrenaline
  • Standard of Care

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators