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

Recruiting

• Conditions: Hemostatic
• Interventions: Device: Purabond

• Registration Number: NCT05733585
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study Start: 2023-02-15
• Study First Posted: 2023-02-17
• Primary Completion: 2024-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with abdominal aortic pathology	Purabond	Patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent.

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis	during the surgery	time that goes from declamping to closing the abdomen

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milano, Italy