The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
研究概览
简要总结
Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis
详细描述
Patients with venous and/or arterial thrombosis aged 18 to 60 years are included.Thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. In addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. The primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. For this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis.
As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-60 years
- •Written informed consent of the patient
- •Spontaneous arterial and/or venous thrombosis
- •infection-associated arterial and/or venous thrombosis within 30 days of infection
- •Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
- •Recurrent arterial or venous thrombosis despite anticoagulant therapy
排除标准
- •Lack of consent of the patient
- •Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
- •Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
- •Thromboses more than 120 days old at the time of blood sampling
结局指标
主要结局
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
时间窗: Day 1
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
次要结局
未报告次要终点
研究者
Prof. Dr. med. E. Lindhoff-Last
Clinical Professor
Cardioangiologisches Centrum Bethanien