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Venous Thromboembolism (VTE)PERSEUSNCT07855679

Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance

An observational study of Venous Thromboembolism (VTE) and Chronic Thromboembolic Pulmonary Hypertension, run by Azienda Ospedaliero-Universitaria Careggi at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

PERSEUS is an academic, investigator-initiated, multicenter observational registry of adults with acute pulmonary embolism (PE), promoted by Azienda Ospedaliero-Universitaria Careggi (Florence, Italy). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Routine clinical care (no study intervention)
How many people
5,000 participants
Where
16 sitesin 3 countries
Study dates
19 Jun 2026to Jul 2032
How long will I take part?
5 Years
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: Consecutive adults with objectively confirmed acute pulmonary embolism diagnosed at participating hospitals, from emergency department presentation through hospitalization, including patients presenting with obstructive shock or cardiac arrest.

Who may be able to join

  • Age 18 years or older at the time of presentation.
  • Objectively confirmed diagnosis of acute pulmonary embolism (PE), with or without concomitant deep vein thrombosis (DVT) of the lower or upper extremities, confirmed by at least one of the following methods:
  • Computed tomography pulmonary angiography (CTPA) demonstrating intraluminal filling defects in the pulmonary arterial tree;
  • Ventilation/perfusion (V/Q) lung scintigraphy demonstrating high-probability mismatch;
  • Conventional catheter-directed pulmonary angiography;
  • In hemodynamically unstable patients (obstructive shock or cardiac arrest) in whom definitive imaging is not feasible: bedside point-of-care ultrasound showing clear signs of right ventricular overload together with proximal deep vein thrombosis, or mobile right heart thrombi.
  • For the retrospective cohort: availability of medical records documenting clinical presentation and index diagnostic work-up at baseline (T0). The absence of serial reassessment timepoints (T1-T4) does not constitute an exclusion criterion.
  • Written informed consent obtained from the patient or legal surrogate, or waiver/exception under Article 110-bis of the Italian Privacy Code (and applicable institutional ethical clearance) for deceased or untraceable patients.

Who cannot join

  • Current active enrollment in an interventional experimental drug trial (blinded randomized clinical trial) where active drug allocation or protocol-mandated therapeutic regimen is unknown.

Trial locations and contacts

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Simone Vanni, MD, PhD contact

+393666904459

simone.vanni@unifi.it

Matteo Gabriele Monda, MD contact

+393209433394

matteogabriele.monda@gmail.com

16 sites in 3 countries

Italy14 sites, 14 recruiting

  • Ospedale Santa Maria Annunziata - Azienda USL Toscana Centro

    Bagno a Ripoli, Tuscany, 50012

    Germana Ruggiano, MD, +39 055 69361, germana.ruggiano@uslcentro.toscana.it

    Recruiting

  • Nuovo Ospedale del Mugello - Azienda USL Toscana Centro

    Borgo San Lorenzo, Tuscany, 50032

    Leonardo Delli, MD, +39 055 84511, leonardo.delli@uslcentro.toscana.it

    Recruiting

  • Ospedale San Giuseppe - Azienda USL Toscana Centro

    Empoli, Tuscany, 50053

    Paola Bartalucci, MD, +39 0571 7051, paola.bartalucci@uslcentro.toscana.it

    Recruiting

  • Ospedale Santa Maria Nuova - Azienda USL Toscana Centro

    Florence, Tuscany, 50122

    Michele Lanigra, MD, +39 055 69381, michele.lanigra@uslcentro.toscana.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134

    Simone Vanni, MD, PhD, +393666904459, simone.vanni@unifi.it

    Matteo Gabriele Monda, MD, +393209433394, matteogabriele.monda@gmail.com

    Recruiting

  • Ospedale San Giovanni di Dio (Torregalli) - Azienda USL Toscana Centro

    Florence, Tuscany, 50143

    Gianfranco Giannasi, MD, +39 055 69321, gianfranco.giannasi@uslcentro.toscana.it

    Recruiting

  • Ospedale Versilia - Azienda USL Toscana Nord Ovest

    Lido di Camaiore

    Gisueppe Pepe, MD, +3905846051, giuseppe.pepe@uslnordovest.toscana.it

    Giuseppe Pepe, MD

    Recruiting

  • AORN Antonio Cardarelli

    Naples, 80131

    Angela Iannuzzi, MD, +390817471111, angela.iannuzzi@aocardarelli.it

    Angela Iannuzzi, MD

    Recruiting

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, 06129

    Cecilia Becattini, MD, PhD, +390755781, cecilia.becattini@unipg.it

    Cecilia Becattini, MD, PhD

    Recruiting

  • Ospedale Santi Cosma e Damiano - Azienda USL Toscana Centro

    Pescia, Tuscany, 51017

    Gianluca Buffini, MD, +39 0572 4601, gianluca.buffini@uslcentro.toscana.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Pisana - Ospedale Cisanello

    Pisa

    Lorenzo Ghiadoni, MD, PhD, +39050992111, lorenzo.ghiadoni@unipi.it

    Lorenzo Ghiadoni, MD, PhD

    Recruiting

  • Ospedale San Jacopo - Azienda USL Toscana Centro

    Pistoia, Tuscany, 51100

    Mirco Donati, MD, +39 0573 3521, mirco.donati@uslcentro.toscana.it

    Recruiting

  • Ospedale Santo Stefano - Azienda USL Toscana Centro

    Prato, Tuscany, 59100

    Matteo Gabriele Monda, MD, +393209433394, matteogabriele.monda@gmail.com

    matteogabriele.monda@gmail.com

    Recruiting

  • AOU Città della Salute e della Scienza di Torino - Presidio Molinette

    Torino, 10126

    Fulvio Morello, MD, +390116335555, fulvio.morello@unito.it

    Fulvio Morello, MD

    Recruiting

Other trials in Italy

Poland1 site, 1 recruiting

  • Medical University of Warsaw - Infant Jesus Teaching Hospital

    Warsaw

    Piotr Pruszczyk, MD, PhD, +48225021000, piotr.pruszczyk@wum.edu.pl

    Piotr Pruszczyk, MD, PhD

    Recruiting

Other trials in Poland

Spain1 site, 1 recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    David Jiménez, MD, PhD, +34913368000, djimenez.hrc@gmail.com

    David Jiménez, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: The PERSEUS Registry - Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance

PERSEUS is an academic, investigator-initiated, multicenter observational registry of adults with acute pulmonary embolism (PE), promoted by Azienda Ospedaliero-Universitaria Careggi (Florence, Italy). It collects data generated during routine care across the whole course of the disease: pre-hospital care when available, emergency department presentation, the hospital stay (including bedside reassessments in the first 48 hours when performed as part of care) and follow-up up to 5 years. The registry has a retrospective cohort (patients diagnosed from 1 January 2023 until local ethics committee approval, with data taken from medical records) and a prospective cohort (consecutive patients enrolled after approval). Taking part in the registry does not change patient care: all tests and treatments are decided by the treating physicians. The registry aims to describe how acute PE is managed in everyday practice and how often patients die (from any cause and from PE), deteriorate hemodynamically, have recurrent venous thromboembolism or bleeding, and develop long-term complications such as chronic thromboembolic pulmonary hypertension. The database also supports ancillary analyses with separate pre-specified analysis plans, such as the evaluation of existing risk-stratification tools.

Read the detailed description

BACKGROUND AND SCIENTIFIC RATIONALE

Pulmonary embolism (PE) represents a major cause of emergency department (ED) presentation, critical care admission, and early mortality. Despite advances in diagnostic algorithms and therapeutic strategies, intermediate- and high-risk PE patients remain challenging to risk-stratify dynamically during the acute phase. Current prognostic tools often rely solely on baseline single-point parameters, neglecting acute pathophysiological changes during the initial 48 hours of treatment. The PERSEUS Registry is designed to bridge this gap by capturing comprehensive, granular real-world data spanning the acute presentation, dynamic in-hospital course, and long-term surveillance.

STUDY DESIGN AND COHORTS

Time perspective: ambispective (retrospective and prospective cohorts, described below).

PERSEUS is an observational, ambispective, multicenter registry comprising two distinct phases:

  1. Retrospective Phase (Historical Cohort): Includes consecutive adult patients diagnosed with acute PE from January 1, 2023, up to the date of local Ethics Committee approval at each participating site. Data are abstracted from medical records.
  2. Prospective Phase (Contemporary Cohort): Enrolls consecutive adult patients presenting with acute PE after local Ethics Committee approval, extending for a continuous enrollment period of 5 years. Data are collected during routine care.

STUDY SETTING AND CLINICAL CONTINUUM OF CARE

Data collection spans the entire continuum of clinical care across participating academic, tertiary, and regional hospitals:

  • Baseline Presentation (T0): Captures pre-hospital emergency medical service (EMS) data (initial vital signs, cardiac arrest, point-of-care ultrasound [POCUS], pre-hospital anticoagulation or thrombolysis), ED arrival parameters, clinical symptoms, arterial blood gas analysis, admission laboratory biomarkers (high-sensitivity troponin, BNP/NT-proBNP, lactate, D-dimer, renal function), electrocardiographic patterns, and multiorgan diagnostic imaging (CT pulmonary angiography [CTPA], complete echocardiography/POCUS, and compression venous ultrasound [CUS]).
  • Dynamic In-Hospital Reassessment (T1-T4): To capture real-world hemodynamic and respiratory trajectories, serial parameters documented during standard clinical monitoring are recorded across predefined temporal windows: T1 (3-6 hours), T2 (6-12 hours), T3 (12-24 hours), and T4 (24-48 hours). Parameters include serial vital signs, shock index, respiratory support modalities, serial lactate/troponin kinetics, echocardiographic right ventricular function changes, and need for escalating hemodynamic or respiratory support (vasopressors, inotropes, non-invasive ventilation, mechanical ventilation, or ECMO).
  • Hospital Discharge \& Complications: Documents in-hospital adverse events, need for rescue reperfusion, procedural complications, bleeding events, length of stay, and vital status at discharge.
  • Follow-up Surveillance: Thirty-day status is ascertained from clinical records. Follow-up then reflects routine care at 3 and 12 months and annually thereafter up to 5 years (in-person visit, telemedicine, telephone contact or review of clinical documentation), with regional mortality registries used to ascertain vital status when needed. Follow-up collects all-cause survival, cause of death, VTE recurrence, major and clinically relevant non-major bleeding, persistent functional limitation (modified Rankin Scale, exertional dyspnea, six-minute walk test when performed) and the development of chronic thromboembolic pulmonary hypertension (CTEPH).

OUTCOMES

Outcome definitions and time frames are reported in the Outcome Measures section.

DATA MANAGEMENT, QUALITY ASSURANCE, AND ETHICAL GOVERNANCE

Data collection is centralized using an electronic Case Report Form (eCRF) deployed on the REDCap (Research Electronic Data Capture) platform hosted on secure institutional servers at Azienda Ospedaliero-Universitaria Careggi (Florence, Italy).

  • Privacy and Data Segregation: Strict GDPR compliance is maintained. Patient data are pseudonymized at source by the local site investigator using site-specific Subject IDs. The decoding key linking the alphanumeric ID to personal identifiers is maintained exclusively at the local participating hospital under the responsibility of the local Principal Investigator.
  • Data Access Groups (DAGs): REDCap DAGs are enforced to compartmentalize site-level access, ensuring participating centers can exclusively view, enter, and edit their own center's records, with no unauthorized cross-center data visibility.
  • Quality Assurance: The eCRF includes built-in validation rules (range and logic checks). The coordinating center performs regular central monitoring for inconsistencies, outliers and missing data, and discrepancies are resolved with each center through a formal query process. The Steering Committee reviews enrollment, data quality and protocol adherence every 6 months.
  • Regulatory Framework: Protocol version 2.0 (7 May 2026) received a favourable opinion from the Comitato Etico Regione Toscana - Area Vasta Centro (CEAVC, register no. 30742_oss, meeting of 9 June 2026) for the sites of Azienda Ospedaliero-Universitaria Careggi and Azienda USL Toscana Centro. Participation of other national and international centers is subject to approval of a protocol amendment and of the competent local ethics committees. The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice principles and applicable privacy regulations (including Article 110-bis of the Italian Privacy Code).
Being tested
Routine clinical care (no study intervention)
Keywords
Pulmonary Embolism, Acute Pulmonary Embolism, Venous Thromboembolism, Right Ventricular Dysfunction, Risk Stratification, Prognostic Scores, TELOS-plus, sPESI, Bova Score, ESC Guidelines, AHA/ACC Guidelines, High-Sensitivity Troponin, Plasma Lactate, Echocardiography, CT Pulmonary Angiography, Hemodynamic Decompensation, Systemic Thrombolysis, Catheter-Directed Therapy, Observational Registry, Real-World Evidence
Medical subject headings
Venous Thromboembolism, Ventricular Dysfunction, Right, Pulmonary Embolism, Emergencies, Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine clinical care (no study intervention)Other

    Also called Routine Clinical Practice, Usual Care

    Observational registry. Diagnostic and therapeutic management (laboratory tests, imaging, bedside ultrasound, anticoagulation, reperfusion and hemodynamic support) is entirely at the discretion of the treating physicians, according to routine institutional pathways and international guidelines. The registry only collects data generated in routine care.

Study groups in NCT07855679
Study groupRoleWhat they receive
Adults with acute pulmonary embolismConsecutive adults with objectively confirmed acute pulmonary embolism, in two cohorts: a retrospective cohort (diagnoses from 1 January 2023 until local ethics committee approval; data abstracted from medical records) and a prospective cohort (consecutive enrollment after approval, for 5 years; data collected during routine care).
Receives: Other: Routine clinical care (no study intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at 30 days

    Proportion of patients who die from any cause within 30 days of the objectively confirmed diagnosis of acute pulmonary embolism. Vital status is ascertained from hospital records, review of clinical documentation and, when needed, regional mortality registries.

    Measured: 30 days after diagnosis

  2. PE-related mortality at 30 days

    Proportion of patients whose death within 30 days is adjudicated as a direct consequence of the index or a recurrent pulmonary embolism (PE). Fatal PE is defined as death occurring after objectively confirmed PE (index or recurrent event) in the absence of other identifiable causes, or confirmed at autopsy. For deaths occurring at home, information on the cause of death is actively sought.

    Measured: 30 days after diagnosis

Secondary outcomes (8)

  1. Hemodynamic decompensation

    Proportion of patients with new occurrence, after the initial assessment, of at least one of: persistent hypotension (systolic blood pressure <90 mmHg for 15 minutes or longer) or shock; need for continuous vasopressor or inotrope infusion; invasive mechanical ventilation; cardiac arrest; rescue reperfusion therapy (systemic, catheter-directed or surgical) for clinical deterioration. Reperfusion given as the initial treatment strategy is not counted as an event.

    Measured: From diagnosis to hospital discharge or day 30, whichever comes first

  2. All-cause mortality during follow-up

    Proportion of patients who die from any cause during follow-up.

    Measured: 3 months, 12 months, and annually up to 5 years after diagnosis

  3. PE-related mortality during follow-up

    Proportion of patients whose death during follow-up is adjudicated as a direct consequence of the index or a recurrent pulmonary embolism, as defined for the 30-day PE-related mortality outcome.

    Measured: 3 months, 12 months, and annually up to 5 years after diagnosis

  4. Recurrent venous thromboembolism

    Proportion of patients with any new episode of pulmonary embolism or deep vein thrombosis (lower or upper limb, proximal or distal) confirmed by objective testing. Superficial vein thrombosis is not counted.

    Measured: 30 days, 3 months, 12 months, and annually up to 5 years after diagnosis

  5. Major bleeding (ISTH criteria)

    Proportion of patients with major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH): overt bleeding that is fatal; or occurs in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome); or causes a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or leads to transfusion of two or more units of whole blood or red cells. Major bleeding is additionally classified as life-threatening if it is extracranial bleeding causing shock or intracranial hemorrhage with a Glasgow Coma Scale score below 14.

    Measured: 30 days, 3 months, 12 months, and annually up to 5 years after diagnosis

  6. Clinically relevant non-major bleeding

    Proportion of patients with bleeding not meeting the criteria for major bleeding but requiring medical intervention, unscheduled contact with a physician, or temporary cessation of antithrombotic therapy.

    Measured: 30 days, 3 months, 12 months, and annually up to 5 years after diagnosis

  7. Chronic thromboembolic pulmonary hypertension (CTEPH)

    Proportion of patients with CTEPH diagnosed during routine follow-up: mean pulmonary arterial pressure >20 mmHg, pulmonary arterial wedge pressure ≤15 mmHg and pulmonary vascular resistance >2 Wood units at right heart catheterization, with mismatched perfusion defects after at least 3 months of therapeutic anticoagulation (2022 ESC/ERS criteria). Diagnostic tests are performed only when clinically indicated.

    Measured: 30 days, 3 months, 12 months, and annually up to 5 years after diagnosis

  8. Persistent functional limitation after pulmonary embolism (post-PE syndrome)

    Persistent or worsened exertional dyspnea compared with pre-event status, modified Rankin Scale score, and six-minute walk distance when performed in routine care.

    Measured: 30 days, 3 months, 12 months, and annually up to 5 years after diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start19 Jun 2026
  3. Primary completionJul 2031 (estimated)
  4. Study completionJul 2032 (estimated)

Resources

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
Other
Enrolment
5,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07855679
Sponsor's protocol ID
PERSEUS
Other IDs
30742_oss
Acronym
PERSEUS
Status last verified
Oct 2026
First submitted
28 Sep 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudonymized individual participant data underlying published results may be shared with qualified researchers for methodologically sound proposals that fall within the scientific scope of the registry and do not overlap with analyses planned by the PERSEUS investigators. Sharing requires approval by the PERSEUS Steering Committee, approval by the competent ethics committee and a data transfer agreement with Azienda Ospedaliero-Universitaria Careggi, in compliance with the GDPR and the Italian Privacy Code.

Publications

  • Barco S, Mahmoudpour SH, Valerio L, Klok FA, Munzel T, Middeldorp S, Ageno W, Cohen AT, Hunt BJ, Konstantinides SV. Trends in mortality related to pulmonary embolism in the European Region, 2000-15: analysis of vital registration data from the WHO Mortality Database. Lancet Respir Med. 2020 Mar;8(3):277-287. doi: 10.1016/S2213-2600(19)30354-6. Epub 2019 Oct 12.

    PubMed 31615719

  • Jimenez D, de Miguel-Diez J, Guijarro R, Trujillo-Santos J, Otero R, Barba R, Muriel A, Meyer G, Yusen RD, Monreal M; RIETE Investigators. Trends in the Management and Outcomes of Acute Pulmonary Embolism: Analysis From the RIETE Registry. J Am Coll Cardiol. 2016 Jan 19;67(2):162-170. doi: 10.1016/j.jacc.2015.10.060.

    PubMed 26791063

  • Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.

    PubMed 10227218

  • Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.

    PubMed 18296591

  • Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.

    PubMed 36017548

  • Franco L, Becattini C, Beyer-Westendorf J, Vanni S, Nitti C, Re R, Manina G, Pomero F, Cappelli R, Conti A, Agnelli G. Definition of major bleeding: Prognostic classification. J Thromb Haemost. 2020 Nov;18(11):2852-2860. doi: 10.1111/jth.15048. Epub 2020 Sep 11.

    PubMed 32767653

  • Vanni S, Pelagatti L, Caviglioli C, Fabiani G, Caldi F, Pellegrino A, Ottaviani M, Innocenti F, Nazerian P. TELOS-plus identifies normotensive patients with pulmonary embolism at high risk of 30-day mortality. Int J Cardiol. 2026 Feb 1;444:133974. doi: 10.1016/j.ijcard.2025.133974. Epub 2025 Oct 22.

    PubMed 41135774

  • Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

    PubMed 31504429

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism (VTE) and Chronic Thromboembolic Pulmonary Hypertension, run by Azienda Ospedaliero-Universitaria Careggi at 16 sites in 3 countries.

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 8 inclusion and 1 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy, Poland, Spain. 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 Simone Vanni, MD, PhD (+393666904459, simone.vanni@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at 30 days (time frame: 30 days after diagnosis). The study lists 2 primary outcomes in all. 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 NCT07855679, which also lists 8 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 15 Oct 2026.

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