Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Treatments: Diagnostic Test: Endogenous thrombin potential; Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Rotational thromboelastometry; Diagnostic Test: Light transmission aggregometry

Study type: Observational

Funder types: Other

Identifiers

NCT03195543

ΕΒΔ410/17-9-14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pulmonary Arterial Hypertension,
• Chronic Thromboembolic Pulmonary Hypertension.

Exclusion criteria

• 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.

Trial design

60 participants in 2 patient groups

Patients with PAH

Description:

Diagnostic tests will be performed on patients with Pulmonary Artery Hypertension in order to assess any blood coagulation disorders. Platelet function, coagulation and fibrinolysis will be evaluated by platelet function analyzer-100 (PFA-100), light transmission aggregometry, rotational thromboelastometry (ROTEM) and endogenous thrombin potential.

Treatment:

Diagnostic Test: Rotational thromboelastometry

Diagnostic Test: Light transmission aggregometry

Diagnostic Test: Endogenous thrombin potential

Diagnostic Test: Platelet function analyzer-100

Patients with CTEPH

Description:

Diagnostic tests will be performed on patients with Chronic Thromboembolic Pulmonary Hypertension in order to assess any blood coagulation disorders. Platelet function, coagulation and fibrinolysis will be evaluated by platelet function analyzer-100 (PFA-100), light transmission aggregometry, rotational thromboelastometry (ROTEM) and endogenous thrombin potential.

Treatment:

Diagnostic Test: Rotational thromboelastometry

Diagnostic Test: Light transmission aggregometry

Diagnostic Test: Endogenous thrombin potential

Diagnostic Test: Platelet function analyzer-100