跳至主要内容
临床试验/NCT03909399
NCT03909399Unknown不适用

Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.

Hellenic Society of Medical Oncology1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Recording all objectively confirmed VTE events for 500 patients during the treatment period

研究概览

简要总结

Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.

详细描述

Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a highly prevalent complication of malignancy. The development of VTE in cancer patients is associated with several adverse consequences including worsened short- and long-term prognosis and survival, mortality, morbidity, chemotherapy postponement, potential hospitalization, need for long-term anticoagulation with attendant bleeding complications and high rates of recurrent VTE . In addition, VTE leads to significant consumption of health care resources; in one study of cancer patients, the adjusted mean incremental all-cause health care costs of VTE were $30,538 per patient. Therefore, the optimal prevention and treatment of VTE are crucial components of patient care in this population. Currently, Low-Molecular-Weight Heparin (LMWH), is the gold standard for the CAT management for the last 15 years Moreover, in a variety of high-risk thrombosis clinical settings, LMWHs agents are safe and effective in preventing VTE. Multiple randomized trials of thromboprophylaxis have been conducted focusing on ambulatory cancer patients receiving chemotherapy. ESMO and ASCO current guidelines suggest considering thromboprophylaxis in high-risk ambulatory cancer patients with LMWHs. ECOG index, metastatic malignancy, chemotherapy and history of thrombosis were significantly associated with the decision to use thromboprophylaxis in most situations.

Additionally, in 2016 Hellenic Society of Medical Oncology (HeSMO) has conducted the GMaT study to assess the awareness of Thrombosis and highlight the current clinical practice in Greece. The study has precluded adoption of outpatient prophylaxis in largely unselected patients with cancer without significant adverse events. Based on GMaT findings, the investigators will proceed in an observational study focusing on thromboprophylaxis in cancer patients with high thrombotic cancer types. In particular, the title of this new study will be "Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT".

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Recording all objectively confirmed VTE events for 500 patients during the treatment period

时间窗: 1 YEAR

Recording the rate of symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and vena cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and P, will also be recorded the agent, the dose and the duration of the antithrombotic therapy

次要结局

未报告次要终点

研究者

发起方
Hellenic Society of Medical Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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