Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair
NCT ID: NCT05733585
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-02-15
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with abdominal aortic pathology
Patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent.
Purabond
hemostatic efficacy of PuraBond
Interventions
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Purabond
hemostatic efficacy of PuraBond
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Mascia Daniele
Principal Investigator
Locations
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IRCCS San Raffaele Hospital
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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PuraBond Study
Identifier Type: -
Identifier Source: org_study_id
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