Investigating PuraBond for controlling bleeding during abdominal aorta surgery
Official title: "A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
Run by IRCCS San Raffaele · NCT05733585 · Data updated 2026-11-12
This study is testing if the PuraBond hemostatic agent can help control bleeding during abdominal aorta surgery for patients who struggle with standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | February 15, 2023 |
| Main results expected | February 27, 2024 |
| Study ends | October 31, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT05733585 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with abdominal aortic aneurysms or steno-occlusive disease who are undergoing open surgical repair.
✕Probably not a fit
Patients with preoperative coagulation issues, those requiring endovascular treatment, 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 observational study aims to evaluate the effectiveness of the PuraBond hemostatic agent in achieving hemostasis during open repair surgeries for patients with abdominal aortic conditions, such as aneurysms or steno-occlusive disease. Conducted at the Vascular Surgery Department of San Raffaele Hospital in Milan, Italy, the study will enroll 100 patients who require surgical intervention. The focus is on patients who do not achieve satisfactory hemostasis with standard techniques, allowing for a targeted assessment of PuraBond's efficacy.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by enhancing hemostatic control during complex abdominal aorta repairs.
How similar studies have gone: While the specific use of PuraBond in this context may be novel, similar hemostatic agents have shown promise in other surgical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with ≥ 18 years of age, presenting with an abdominal aortic aneurysm (pararenal, juxtarenal, infrarenal, aorto-iliac mono/bilateral) * Use of the Purabond hemostatic agent in patients who, in the opinion of the Physician, don't have a satisfactory surgical haemostasis * Patients ≥ 18 years of age with steno-occlusive abdominal aortic or iliac disease * Patients that will treated by open repair , encompassing elective, urgent and emergency presentation, hospitalized and enrolled in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy) * Patients able to sign specific informed consent for the study Exclusion Criteria: * Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver function * Patients with abdominal aortic and/or iliac arteries disease candidate for endovascular treatment * Pregnant, breastfeeding, or planning on becoming pregnant within 24 months * Systemic infection (for example: sepsis) * Impossibility or refusal to give informed consent
Where it's running
-
IRCCS San Raffaele Hospital
Milan, Italy, Italy Recruiting
Study contacts
- Study coordinator: Daniele Mascia, MD
- Email: mascia.daniele@hsr.it
- Phone: +390226437141
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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.