Real World Study of Deep Venous Thrombosis in Brazil. Analysis of Prospective Cases in University Hospitals in the State of São Paulo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Incidence of risk factors for DVT
研究概览
简要总结
Background: Deep venous thrombosis (DVT) is a common and important vascular disease due to its morbidity and mortality.
Its incidence remains high throughout the world and constitutes serious problems for national and international public health.
Several inherited and/or acquired risk factors may be responsible for thrombus formation. Few epidemiological data regarding real world panorama of this disease in South America and Brazil is available in the literature.
Objective: Evaluate demographic data, diagnostic methods and treatment of deep vein thrombosis in the real world in public university hospitals in Brazil.
Methods: Five-year prospective records of deep venous thrombosis have been collected by the RHEUNI group of five public schools in the State of São Paulo.
Demographic data of patients will be evaluated along with the main risk factors, clinical picture, diagnostic methods, use of different drugs to treat the disease and its complications. Digital platform has been used in data collection. Is a multicenter study and analysis will be performed using Microsoft Excel and Epi-Info.
Key words: deep vein thrombosis, assessment, risk factors, demographic data.
详细描述
Introduction DVT is a multidisciplinary disease, mainly as consequence of surgical or clinical conditions, and the acute pulmonary embolism and the post-thrombotic syndrome (PTS) are the most serious complications.
The incidence of deep venous thrombosis of the lower limbs in the population is from 0.2 to 0.7 cases per 1,000 inhabitants/year and in Brazil an estimated incidence of 0.6 cases/1000 inhabitants/year has been estimated.
Risk factors for DVT include: advanced age, history of immobilization or prolonged bed rest during hospitalization, obesity, smoking, recent surgery, previous VTE episodes, cancer, major or lower limb trauma, cancer therapy, acute infectious disease, heart failure, respiratory insufficiency, contraceptive use or hormone replacement therapy, pregnancy or postpartum, stroke with motor deficit, family history of VTE (thrombophilia).
The clinical diagnosis of DVT, based on physical examination only, is imprecise and insensitive and only one-third or less of the clinical suspicions are confirmed by imaging tests.
The primary goals of DVT treatment are to prevent and / or treat their complications. Anticoagulant therapy is efficacious but associated to some risk of bleeding. Mechanical prophylactic measures (ambulation and use of elastic stockings with gradual compression) are important in high risk patients and in cases with contraindication of anticoagulants.
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
- 否
入选标准
- •patients with venous thrombosis in any site, male or female, regardless of age, with first episode or recurrent episodes and with or without pulmonary embolism.
排除标准
- •There are no exclusion criteria
结局指标
主要结局
Incidence of risk factors for DVT
时间窗: Five Years
1. Inheriting a blood-clotting disorder. 2. Prolonged bed rest, such as during a long hospital stay, or paralysis. 3. Injury or surgery. 4. Pregnancy. 5. Birth control pills (oral contraceptives) or hormone replacement therapy. 6. Being overweight or obese. 7. Smoking. 8. Cancer. 9. Heart failure. 10. Inflammatory bowel disease. 11. A personal or family history of deep vein thrombosis or pulmonary embolism. 12. Age. Being older than 60 increases your risk of DVT.
次要结局
- Types of treatment performed in the real world(Five Years)
研究者
Selma Regina de Oliveira Raymundo
Principal Investigator
Fundação Faculdade Regional de Medicina de São José do Rio Preto