HemostaticNCT05733585
Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair
An observational study of Hemostatic, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostatic
- What is being tested?
- Purabond
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Hospital
Milan, Italy, 20132
Daniele Mascia, MD, +390226437130, mascia.daniele@hsr.it
Elisa Simonini, DR, +390226437141, simonini.elisa@hsr.it
About this study
Official title: "A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
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.
- Conditions
- Hemostatic
- Being tested
- Purabond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurabondDevice
hemostatic efficacy of PuraBond
| Study group | Role | What they receive |
|---|---|---|
| Patients with abdominal aortic pathology | Patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent. Receives: Device: Purabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
time that goes from declamping to closing the abdomen
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start15 Feb 2023
- Primary completion27 Feb 2024
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemostaticStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mascia Daniele, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733585
- Sponsor's protocol ID
- PuraBond Study
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23642926Diehm 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.
PubMed 14709362Shander 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.
PubMed 25151345
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
- ClinicalTrials.gov ID
- NCT05733585
- Acronym / sponsor ID
- PuraBond Study
- Conditions
- Hemostatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with abdominal aortic pathology | – | Device: PurabondPatients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purabondhemostatic efficacy of PuraBond | Device | Patients with abdominal aortic pathology |
Primary outcome
Time to Hemostasis
Time frame: during the surgery
time that goes from declamping to closing the abdomen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 23642926Berger 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.
- Background: PubMed 14709362Diehm 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.
- Background: PubMed 25151345Shander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostatic, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Mascia, MD (+390226437141 ext. 7141, mascia.daniele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hemostasis (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05733585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.