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NCT Number: NCT05733585

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

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.

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Key information

Conditions

Hemostatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Purabond

Device

hemostatic efficacy of PuraBond

Primary outcomes

  1. Time to Hemostasis

    Time frame: during the surgery

    time that goes from declamping to closing the abdomen

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Mascia, MD

CONTACT

[email protected]

+390226437141 ext. 7141

Elisa Simonini, DR

CONTACT

[email protected]

+390226437141 ext. 7141

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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