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NCT05733585
A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair
Conditions: Hemostatic
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: IRCCS San Raffaele
Location: Italy
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 Criteria:Patients with ≥ 18 years of age, presenting with an abdominal aortic aneurysm (pararenal, iuxtarenal, 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 haemostasisPatients ≥ 18 years of age with steno-occlusive abdominal aortic or iliac diseasePatients 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 studyExclusion Criteria:Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver functionPatients with abdominal aortic and/or iliac arteries disease candidate for endovascular treatmentPregnant, breastfeeding, or planning on becoming pregnant within 24 monthsSystemic infection (for example: sepsis)Impossibility or refusal to give informed consent
Source: ClinicalTrials.gov (NCT05733585). StuddyBuddy aggregates publicly available trial information.