Using PuraStat® with Adrenaline for treating upper gastrointestinal bleeding
Official title: PuraStat® Combined With Adrenaline Versus Standard of Care in Non-variceal Upper Gastrointestinal Bleeding. Multicentric International Clinical Trial.
Run by Tallaght University Hospital · NCT06896409 · Data updated 2026-11-12
This study is testing if using a special gel called PuraStat® with Adrenaline can help people with upper gastrointestinal bleeding do better than the usual treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Tallaght University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lleida) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | October 2025 |
| Study ends | October 2025 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT06896409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who are undergoing endoscopic therapy for non-variceal gastrointestinal bleeding.
✕Probably not a fit
Patients with variceal or portal hypertension-related gastrointestinal bleeding, or those who are pregnant or breastfeeding, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of PuraStat®, a novel hemostatic gel, combined with Adrenaline compared to standard care in managing upper gastrointestinal bleeding (UGIB). The study aims to determine if this combination can provide better outcomes in terms of hemostasis and reduce re-bleeding rates. Participants will undergo endoscopic therapy, and the trial will assess the safety and efficacy of the treatment approach. The study is designed as a prospective, randomized, parallel-group, open-label trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of upper gastrointestinal bleeding, leading to better patient outcomes.
How similar studies have gone: While there is limited data on PuraStat® for UGIB, other hemostatic agents have shown success in similar applications, indicating potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Arnau de Vilanova de Lleida
Lleida, Spain Recruiting
Study contacts
- Study coordinator: Raquel Ballester
- Email: rballester.lleida.ics@gencat.cat
- Phone: 973705342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.