The study is classified as an observational study involving the use of medication,
spontaneous, multicentric, 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.
The study, including data analysis, is expected to conclude by 31/12/2027. Patients have
been and will be treated according to clinical practice, in accordance with the
physician's judgment and the information provided in the technical datasheet of each
product used for any concomitant therapies administered as per clinical practice. The
diagnostic-therapeutic pathway for patients will not be influenced in any way by the
results of the tissue tests performed for the purposes of the study.
Additionally, patients have been and will be followed according to the usual schedule
defined by current clinical practice and will undergo all standard diagnostic
investigations, both invasive and non-invasive, as prescribed by current clinical
practice.
All 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, will be enrolled from 01/01/2016 to 30/06/2027.
Each patient will be followed according to standard clinical-care practice, with a
follow-up of at least 6 months considered for the purposes of the study.
Considering that the monthly attendance of patients at the Consultation Clinic of 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 is approximately 50 patients, based on the inclusion/exclusion criteria, it
is estimated that about 1,000 patients with a diagnosis of VTE in the context of
neoplasia can be enrolled.
This sample size is considered sufficient to achieve the primary objective of the study.
The primary objective 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, followed in 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 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 used
in clinical practice, without affecting the care process and clinical decisions, in
a prospective cohort of patients with CAT.
The data available in the literature concern the use of anticoagulants (LMWH or DOACs) in
patients with a confirmed diagnosis of venous thromboembolism in the context of
neoplasia. However, it is necessary to stratify these patients in order to identify those
who are more or less at risk of complications, in order to provide a more targeted
therapeutic approach.