RecruitingNot ApplicableNCT06896409

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

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


Sponsor

Tallaght University Hospital

Enrollment

126 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Age \>18 years
  • Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding

Exclusion Criteria3

  • Variceal or portal hypertension-related gastrointestinal bleeding
  • Lack of signed consent form
  • Pregnancy or breastfeeding

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Interventions

COMBINATION_PRODUCTPuraStat® combined with Adrenaline

PuraStat® application (mL) combined with Adrenaline injection (mL)

COMBINATION_PRODUCTStandard of Care

Adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).


Locations(1)

Hospital Arnau de Vilanova de Lleida

Lleida, Spain

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NCT06896409


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