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

NCT ID: NCT06896409

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-10-31

Brief 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.

Detailed Description

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.

To date, most published data on PuraStat® as a haemostatic agent originates from surgical settings. In endoscopy, its primary applications have been in polypectomy-related haemostasis and the promotion of wound healing. Reports indicate a haemostasis success rate of 90.4%, with a recurrence rate of 10.4%. However, data on its efficacy in UGIB lesions remain limited.

This study hypothesizes that PuraStat®, when combined with Adrenaline, represents a feasible and effective first-line treatment for gastrointestinal bleeding, potentially matching or surpassing the current standard of care. A prospective, randomized, parallel-group, open-label clinical trial is proposed. During endoscopy, patients requiring treatment will be randomly assigned to one of two groups: standard care or Adrenaline injection combined with PuraStat®. If haemostasis is not achieved with the initial treatment, the alternative approach will be applied. Patients will be monitored for 30 days to assess bleeding recurrence. The study aims to enroll 126 patients (63 per group).

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PuraStat® combined with Adrenaline

In this experimental arm PuraStat® (mL) will be administered in combination with an injection of Adrenaline (mL).

Group Type: EXPERIMENTAL

PuraStat® combined with Adrenaline

Intervention Type: COMBINATION_PRODUCT

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

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: COMBINATION_PRODUCT

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

Interventions

PuraStat® combined with Adrenaline

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

Intervention Type: COMBINATION_PRODUCT

Standard of Care

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tallaght University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Raquel Ballester

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Arnau de Vilanova de Lleida

Lleida, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Raquel Ballester

Role: CONTACT

rballester.lleida.ics@gencat.cat

973705342

Facility Contacts

Raquel Ballester, MD

Role: primary

Other Identifiers

PUR02

Identifier Type: -

Identifier Source: org_study_id