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Sponsor study identifier
observational
1,000
1 country
2
Study Start
January 2, 2016
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2016
Actual (reported)November 28, 2024
Actual (reported)December 4, 2024
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluation of Thrombotic and Hemorrhagic Complications During Treatment with Low Molecular Weight Heparin or Direct Oral Anticoagulants in Patients with Venous Thromboembolism and Neoplasms
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).
From enrollment to the end of treatment at 6 months
Risk factors for hemorrhagic complications and bleeding risk
From enrollment to the end of treatment at 6 months
Applicability and reliability of a score
From enrollment to the end of treatment at 6 months
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.
IRCCS Azianda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
IRCCS Arcispedale S. Maria Nuova di Reggio Emilia
Reggio Emilia, 42123, Italy
Benilde Cosmi, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
First Submitted
November 28, 2024
First Posted
December 4, 2024
Study Start
January 2, 2016
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 4, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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