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

Last updated: May 5, 2025
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Purabond

Clinical Study ID

NCT05733585
PuraBond Study
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 thePhysician, 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 andemergency presentation, hospitalized and enrolled in Vascular Surgery Unit, SanRaffaele Hospital (Milan, Italy)

  • Patients able to sign specific informed consent for the study

Exclusion

Exclusion Criteria:

  • Patients whom exhibited preoperative derangements in haematological and coagulationprofiles, and baseline derangements in liver function

  • Patients with abdominal aortic and/or iliac arteries disease candidate forendovascular treatment

  • Pregnant, breastfeeding, or planning on becoming pregnant within 24 months

  • Systemic infection (for example: sepsis)

  • Impossibility or refusal to give informed consent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Purabond
Phase:
Study Start date:
February 15, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • IRCCS San Raffaele Hospital

    Milano, 20132
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.