Clinical trial NCT05733585: Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair
Official title: "A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemostatic
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Study will include 100 patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: during the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
citation: Berger JS, Hochman J, Lobach I, Adelman MA, Riles TS, Rockman CB. Modifiable risk factor burden and the prevalence of peripheral artery disease in different vascular territories. J Vasc Surg. 2013 Sep;58(3):673-81.e1. doi: 10.1016/j.jvs.2013.01.053. Epub 2013 May 2.
citation: Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105. doi: 10.1016/s0021-9150(03)00204-1.
citation: Shander A, Kaplan LJ, Harris MT, Gross I, Nagarsheth NP, Nemeth J, Ozawa S, Riley JB, Ashton M, Ferraris VA. Topical hemostatic therapy in surgery: bridging the knowledge and practice gap. J Am Coll Surg. 2014 Sep;219(3):570-9.e4. doi: 10.1016/j.jamcollsurg.2014.03.061. Epub 2014 Jun 2. No abstract available.