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RecruitingNCT05733585

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

"A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study

Sponsor

IRCCS San Raffaele

Enrollment

100 participants

Start Date

Feb 15, 2023

Study Type

OBSERVATIONAL

Conditions

Hemostatic

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DEVICEPurabond

hemostatic efficacy of PuraBond

Locations(1)

IRCCS San Raffaele Hospital

Milan, Italy, Italy

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NCT05733585