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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding

Locations
Other Locations
Spain
Hospital Arnau de Vilanova de Lleida
RECRUITING
Lleida
Contact Information
Primary
Raquel Ballester
rballester.lleida.ics@gencat.cat
973705342
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 126
Treatments
Experimental: PuraStat® combined with Adrenaline
In this experimental arm PuraStat® (mL) will be administered in combination with an injection of Adrenaline (mL).
Active_comparator: Standard of Care
This arm will be the active comparator, will include all types of standard of care currently recommended for the treatment of bleeding lesions, such as, adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).
Related Therapeutic Areas
Sponsors
Leads: Tallaght University Hospital

This content was sourced from clinicaltrials.gov