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

San Donato Group (GSD)

Status

Enrolling

Conditions

Hemostatic

Treatments

Device: Purabond

Study type

Observational

Funder types

Other

Identifiers

NCT05733585

PuraBond Study

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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