Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Light transmission aggreggometry in detection of platelet abnormalities in PAH and CTEPH patients.
研究概览
简要总结
The objective of the present study is to assess blood coagulation disorders in patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. The investigators aim to evaluate any possible coagulation abnormalities related to the patients' primary disease and any possible effects the pulmonary hypertension- specific therapy may have on hemostasis.
详细描述
Pulmonary hypertension (PH) is a chronic, progressive, pulmonary vascular disease with a multifactorial etiology and a not fully elucidated pathophysiological background. There is a complex and not adequately understood association between PH and the coagulation process.
The aim of the present study is to evaluate hemostasis in patients with PH classified as category 1 of the World Health Organization Pulmonary Hypertension Group (Pulmonary Arterial Hypertension, PAH) and 4 (Chronic Thromboembolic Pulmonary Hypertension, CTEPH). Patients with CTEPH are diagnosed as inoperable. The investigators perform diagnostic tests on blood samples collected directly from the pulmonary artery during the right heart catheterization performed as part of the patients' routine medical care for the diagnosis of the disease or for follow-up 6 months after the initiation of PH-specific treatment. All blood samples are processed by platelet function analyzer-100 (PFA-100), light transmission aggregometry (LTA), rotational thromboelastometry (ROTEM) and endogenous thrombin potential (ETP).The primary objective of the study is to assess platelet function, coagulation and anti-coagulation pathways and fibrinolysis in PAH and inoperable CTEPH patients and to investigate the possible effects of PH- specific therapy on hemostasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pulmonary Arterial Hypertension,
- •Chronic Thromboembolic Pulmonary Hypertension.
排除标准
- •renal insufficiency,
- •hepatic insufficiency,
- •thyroid dysfunction,
- •malignancy,
- •active infections,
- •receiving anticoagulant or antiplatelet therapy,
- •history of hemostatic disorders irrelevant to their primary disease,
- •abnormal red blood counts.
结局指标
主要结局
Light transmission aggreggometry in detection of platelet abnormalities in PAH and CTEPH patients.
时间窗: 6 months
Change in the percentage of PAH and CTEPH patients who are detected with platelet abnormalities in LTA testing from the date of the first right heart catheterization performed for the diagnosis of their disease (before treatment implementation) to the date of the second right heart catheterization performed for follow-up (after treatment implementation) at 6 months.
PFA-100 in detection of platelet abnormalities in PAH and CTEPH patients.
时间窗: 6 months
Change in the percentage of PAH and CTEPH patients who are detected with platelet abnormalities in PFA-100 testing from the date of the first right heart catheterization performed for the diagnosis of their disease (before treatment implementation) to the date of the second right heart catheterization performed for follow-up (after treatment implementation) at 6 months.
ROTEM in detection of coagulation abnormalities in PAH and CTEPH patients.
时间窗: 6 months
Change in the percentage of PAH and CTEPH patients who are detected with coagulation abnormalities in ROTEM testing from the date of the first right heart catheterization performed for the diagnosis of their disease (before treatment implementation) to the date of the second right heart catheterization performed for follow-up (after treatment implementation) at 6 months.
Endogenous thrombin potential in detection of thrombin abnormalities in PAH and CTEPH patients.
时间窗: 6 months
Change in the percentage of PAH and CTEPH patients who are detected with thrombin deficits in endogenous thrombin potential testing from the date of the first right heart catheterization performed for the diagnosis of their disease (before treatment implementation) to the date of the second right heart catheterization performed for follow-up (after treatment implementation) at 6 months.
次要结局
未报告次要终点
研究者
Eleni Vrigkou
PhD candidate
National and Kapodistrian University of Athens