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

Hemostatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733585
• Other study ID #: PuraBond Study
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: IRCCS San Raffaele
• Contact: Daniele Mascia, MD
• Phone: +390226437141
• Email: mascia.daniele[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemostatic

Intervention

Device:
• Purabond
hemostatic efficacy of PuraBond

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis	time that goes from declamping to closing the abdomen	during the surgery