NCT05733585

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2023Oct 2027

First Submitted

Initial submission to the registry

February 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 8, 2023

Last Update Submit

March 24, 2026

Conditions

Hemostatic

Outcome Measures

Primary Outcomes (1)

  • Time to Hemostasis

    time that goes from declamping to closing the abdomen

    during the surgery

Study Arms (1)

Patients with abdominal aortic pathology

Patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent.

Device: Purabond

Interventions

PurabondDEVICE

hemostatic efficacy of PuraBond

Patients with abdominal aortic pathology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

RECRUITING

Related 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.

    PMID: 23642926BACKGROUND

  • 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: 14709362BACKGROUND

  • 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: 25151345BACKGROUND

Central Study Contacts

Daniele Mascia, MD

CONTACT

+390226437141mascia.daniele@hsr.it

Elisa Simonini, DR

CONTACT

+390226437141simonini.elisa@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

February 15, 2023

Primary Completion

February 27, 2024

Study Completion (Estimated)

October 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)