Using PuraStat® with Adrenaline for treating upper gastrointestinal bleeding
PuraStat® Combined With Adrenaline Versus Standard of Care in Non-variceal Upper Gastrointestinal Bleeding. Multicentric International Clinical Trial.
NA · Tallaght University Hospital · NCT06896409
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tallaght University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Lleida) |
| Trial ID | NCT06896409 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing endoscopic therapy for non-variceal gastrointestinal bleeding.
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.
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 performed: While there is limited data on PuraStat® for UGIB, other hemostatic agents have shown success in similar applications, indicating potential for this approach.
Eligibility criteria
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 this trial is running
Lleida
- Hospital Arnau de Vilanova de Lleida — Lleida, Spain (RECRUITING)
Study contacts
- Study coordinator: Raquel Ballester
- Email: rballester.lleida.ics@gencat.cat
- Phone: 973705342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Gastrointestinal Bleeding