Thromboembolic and Hemorrhagic Complications of Anticoagulant Treatment in Patients With CAT
NCT ID: NCT06714734
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2016-01-02
2027-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Principal Investigators
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Benilde Cosmi, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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IRCCS Azianda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
IRCCS Arcispedale S. Maria Nuova di Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Benilde Cosmi, DM
Role: primary
Other Identifiers
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CAT-Ther
Identifier Type: -
Identifier Source: org_study_id