Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension
NCT ID: NCT03195543
Last Updated: 2019-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2015-03-12
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with PAH
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.
Platelet function analyzer-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Light transmission aggregometry
Light transmission aggregometry is the gold standard method for assessing platelet function.
Rotational thromboelastometry
ROTEM is a viscoelastic method for hemostasis testing in whole blood.This assay investigates the interaction of blood cells, coagulation factors and their inhibitors during clotting and subsequent fibrinolysis.
Endogenous thrombin potential
The endogenous thrombin potential assesses the amount of thrombin which can be generated after the in vitro activation of coagulation and represents the balance between pro- and anti-coagulant forces in plasma.
Patients with CTEPH
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.
Platelet function analyzer-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Light transmission aggregometry
Light transmission aggregometry is the gold standard method for assessing platelet function.
Rotational thromboelastometry
ROTEM is a viscoelastic method for hemostasis testing in whole blood.This assay investigates the interaction of blood cells, coagulation factors and their inhibitors during clotting and subsequent fibrinolysis.
Endogenous thrombin potential
The endogenous thrombin potential assesses the amount of thrombin which can be generated after the in vitro activation of coagulation and represents the balance between pro- and anti-coagulant forces in plasma.
Interventions
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Platelet function analyzer-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Light transmission aggregometry
Light transmission aggregometry is the gold standard method for assessing platelet function.
Rotational thromboelastometry
ROTEM is a viscoelastic method for hemostasis testing in whole blood.This assay investigates the interaction of blood cells, coagulation factors and their inhibitors during clotting and subsequent fibrinolysis.
Endogenous thrombin potential
The endogenous thrombin potential assesses the amount of thrombin which can be generated after the in vitro activation of coagulation and represents the balance between pro- and anti-coagulant forces in plasma.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic Thromboembolic Pulmonary Hypertension.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Eleni Vrigkou
PhD candidate
Principal Investigators
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Eleni Vrigkou, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Argyrios Tsantes, MD, PhD
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
Iraklis Tsagkaris, MD, PhD
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Apostolos Armaganidis, MD, PhD
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Locations
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Attikon University Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Berger G, Azzam ZS, Hoffman R, Yigla M. Coagulation and anticoagulation in pulmonary arterial hypertension. Isr Med Assoc J. 2009 Jun;11(6):376-9.
Herve P, Humbert M, Sitbon O, Parent F, Nunes H, Legal C, Garcia G, Simonneau G. Pathobiology of pulmonary hypertension. The role of platelets and thrombosis. Clin Chest Med. 2001 Sep;22(3):451-8. doi: 10.1016/s0272-5231(05)70283-5.
Lopes AA, Caramuru LH, Maeda NY. Endothelial dysfunction associated with chronic intravascular coagulation in secondary pulmonary hypertension. Clin Appl Thromb Hemost. 2002 Oct;8(4):353-8. doi: 10.1177/107602960200800407.
Preston IR, Farber HW. Anti-coagulation in pulmonary arterial hypertension: the real blood and guts. J Thorac Dis. 2016 Sep;8(9):E1106-E1107. doi: 10.21037/jtd.2016.08.48. No abstract available.
Remkova A, Simkova I, Valkovicova T. Platelet abnormalities in chronic thromboembolic pulmonary hypertension. Int J Clin Exp Med. 2015 Jun 15;8(6):9700-7. eCollection 2015.
Lang IM, Dorfmuller P, Vonk Noordegraaf A. The Pathobiology of Chronic Thromboembolic Pulmonary Hypertension. Ann Am Thorac Soc. 2016 Jul;13 Suppl 3:S215-21. doi: 10.1513/AnnalsATS.201509-620AS.
Other Identifiers
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ΕΒΔ410/17-9-14
Identifier Type: -
Identifier Source: org_study_id
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