RecruitingNot Applicable

Thromboembolic and Hemorrhagic Complications of Anticoagulant Treatment in Patients With CAT

Italy1,000 participantsStarted 2016-01-02

Plain-language summary

The study is classified as an observational pharmacological study, spontaneous, monocentric, and both retrospective and prospective for adult patients with a diagnosis of venous thromboembolism in the context of neoplasia, followed at the SSD Angiology and Coagulation Disorders of the IRCCS Azienda Ospedaliero-Universitaria di Bologna and The Cardiovascular Medicine Department, specifically the Angiology Unit, of the IRCCS Arcispedale S. Maria Nuova in Reggio Emilia, from 01/01/2016 to 30/06/2027. The study, including data analysis, is expected to conclude by 31/12/2027. Patients were treated according to clinical practice, in accordance with the physician's judgment and the information provided in the product's technical datasheet for any concomitant therapies administered as per clinical practice. The primary objective of the study is to evaluate the frequency of thrombotic and hemorrhagic complications during treatment with low molecular weight heparin or direct oral anticoagulants in patients with venous thromboembolism and solid and hematological neoplasms attending outpatient care at the SSD Angiology and Coagulation Disorders of the IRCCS AOUBO and The Cardiovascular Medicine Department, specifically the Angiology Unit, of the IRCCS Arcispedale S. Maria Nuova in Reggio Emilia, following the initiation of anticoagulant therapy (LMWH or DOACs). The secondary objectives of the study are: * To identify risk factors for hemorrhagic complications and bleeding risk during anticoagulant treatment for CAT; * To assess the applicability and reliability of a score, which is not currently in use in clinical practice, without impacting the care process and clinical decisions, in a prospective cohort of patients with CAT.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of venous thrombosis at any site * Diagnosis of CVC-related venous thrombosis * Diagnosis of pulmonary embolism, both symptomatic and incidental * Diagnosis of solid or hematological neoplasm, either under treatment or active * Obtaining of Informed Consent Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of Thrombotic and Hemorrhagic Complications During Treatment with Low Molecular Weight Heparin or Direct Oral Anticoagulants in Patients with Venous Thromboembolism and Neoplasms

Timeframe: From enrollment to the end of treatment at 6 months

Trial details

NCT IDNCT06714734

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Benilde Cosmi, MD

0512142483 benilde.cosmi@unibo.it

View on ClinicalTrials.gov More Venous Thromboembolism trials