Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Purabond.
- Who it may be relevant to
- Registry conditions: Hemostatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
"A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
Overview
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.
Interventions
- Device Purabond
hemostatic efficacy of PuraBond
Primary outcome measures
- Time to Hemostasis [Time frame: during the surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele Hospital — Milan
Publications
- 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. PMID 23642926
- 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. PMID 14709362
- 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. PMID 25151345
Identifiers
NCT: NCT05733585 · PuraBond Study