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Recruiting Observational

Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair

NCT05733585 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-02-15
Last updated
2026-03-27

Condition(s) studied

Hemostatic

Investigational drug(s) / intervention(s)

Purabond

Purabond: hemostatic efficacy of PuraBond

Study summary

Purabond Study is a physician-initiated, observational, monocentric prospective Trial.

The aim of the study is to investigate the hemostatic efficacy of PuraBond for aortic anastomoses and suture lines in patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair at Vascular Surgery Departement - San Raffaele Hospital (Milan, Italy). The Study will include 100 patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to Hemostasis — during the surgery
    time that goes from declamping to closing the abdomen

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Hospital Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05733585 on ClinicalTrials.gov ↗ ← All trials in Italy