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

NCT06896409 | Recruiting

• 1 other identifier: PUR02
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Absence of rebleeding (recurrence of haematemesis, maelena and /or haematochezia, recurrent tachycardia or hypotension after achieving hemodynamic stability, or a reduction in haemoglobin ≥ 2 g/dL after a stable haemoglobin value has been attained) observed within the first 4 weeks following the initial endoscopic treatment.

  30 days

Secondary Outcomes (2)

• Technical success

  During endoscopy

• Duration of the procedure

  During endoscopy

Other Outcomes (1)

• Level of difficulty

  During endoscopy

Study Arms (2)

PuraStat® combined with Adrenaline

EXPERIMENTAL

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

Combination Product: PuraStat® combined with Adrenaline

Standard of Care

ACTIVE COMPARATOR

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).

Combination Product: Standard of Care

Interventions

PuraStat® combined with Adrenaline COMBINATION_PRODUCT

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

PuraStat® combined with Adrenaline

Standard of Care COMBINATION_PRODUCT

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tallaght University Hospital: lead

Study Sites (1)

Hospital Arnau de Vilanova de Lleida

Lleida, Spain

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Epinephrine; Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Raquel Ballester

CONTACT

973705342; rballester.lleida.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: March 26, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

ES (1)