Thromboembolic and Hemorrhagic Complications of Anticoagulant Treatment in Patients With CAT (Cancer Associated Thrombosis)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Evaluation of Thrombotic and Hemorrhagic Complications During Treatment with Low Molecular Weight Heparin or Direct Oral Anticoagulants in Patients with Venous Thromboembolism and Neoplasms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Evaluation of Thrombotic and Hemorrhagic Complications During Treatment with Low Molecular Weight Heparin or Direct Oral Anticoagulants in Patients with Venous Thromboembolism and Neoplasms
时间窗: From enrollment to the end of treatment at 6 months
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).
次要结局
- 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)