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.

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Combination product: PuraStat® combined with Adrenaline; Combination product: Standard of Care

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).

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raquel Ballester; Phone Number: 973705342; Email: rballester.lleida.ics@gencat.cat

Study Locations

• Spain
  • Lleida, Spain
    • Recruiting
    • Hospital Arnau de Vilanova de Lleida
    • Contact: Raquel Ballester, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PuraStat® combined with Adrenaline; In this experimental arm PuraStat® (mL) will be administered in combination with an injection of Adrenaline (mL).	Combination product: PuraStat® combined with Adrenaline; PuraStat® application (mL) combined with Adrenaline injection (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).	Combination product: Standard of Care; Adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Ability to achieve haemostasis and/or complete the endoscopic treatment satisfactorily	During endoscopy
Duration of the procedure	From the bleeding lesion is detected until the end of the endoscopic treatment.	During endoscopy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of difficulty	Graded in three categories: Very Easy (no difficulties encountered and no effort needed), Easy (mild difficulties and mild effort needed), Difficult (difficulties encountered and a considerable effort needed or Very Difficult (high difficulties and high effort or skills needed to treat the lesion	During endoscopy

Collaborators and Investigators

• Sponsor: Tallaght University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: PUR02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No