Investigating PuraBond for controlling bleeding during abdominal aorta surgery
"A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
IRCCS San Raffaele · NCT05733585
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT05733585 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with abdominal aortic aneurysms or steno-occlusive disease who are undergoing open surgical repair.
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.
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 performed: While the specific use of PuraBond in this context may be novel, similar hemostatic agents have shown promise in other surgical settings.
Eligibility criteria
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 this trial is running
Milan, Italy
- IRCCS San Raffaele Hospital — Milan, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Daniele Mascia, MD
- Email: mascia.daniele@hsr.it
- Phone: +390226437141
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: Hemostatic