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Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03195543
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eleni Vrigkou, National and Kapodistrian University of Athens

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension Diagnostic Test: Platelet function analyzer-100 Diagnostic Test: Light transmission aggregometry Diagnostic Test: Rotational thromboelastometry Diagnostic Test: Endogenous thrombin potential

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.
Actual Study Start Date : March 12, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Platelet function analyzer-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Other Name: PFA-100

Diagnostic Test: Light transmission aggregometry
Light transmission aggregometry is the gold standard method for assessing platelet function.

Diagnostic Test: 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.
Other Name: ROTEM

Diagnostic Test: 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 Name: ETP

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.
Diagnostic Test: Platelet function analyzer-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Other Name: PFA-100

Diagnostic Test: Light transmission aggregometry
Light transmission aggregometry is the gold standard method for assessing platelet function.

Diagnostic Test: 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.
Other Name: ROTEM

Diagnostic Test: 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 Name: ETP




Primary Outcome Measures :
  1. PFA-100 in detection of platelet abnormalities in PAH and CTEPH patients. [ Time Frame: 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.

  2. Light transmission aggreggometry in detection of platelet abnormalities in PAH and CTEPH patients. [ Time Frame: 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.

  3. ROTEM in detection of coagulation abnormalities in PAH and CTEPH patients. [ Time Frame: 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.

  4. Endogenous thrombin potential in detection of thrombin abnormalities in PAH and CTEPH patients. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study participants are recruited among the pulmonary hypertension patients of the Pulmonary Hypertension Unit, In the Second Department of Critical Care Medicine, Attiko University Hospital, Athens, Greece
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195543


Contacts
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Contact: Eleni Vrigkou, MD, MSc 00302105832179 elenivrigkou@gmail.com
Contact: Argyrios Tsantes, MD, PhD 00302105830000 atsantes@med.uoa.gr

Locations
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Greece
Attikon University Hospital Recruiting
Athens, Greece, 12462
Contact: Eleni Vrigkou, MD, MSc    0030-2105832179    elenivrigkou@gmail.com   
Contact: Iraklis Tsagkaris, MD, PhD    0030-2105832179    itsagkaris@med.uoa.gr   
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Eleni Vrigkou, MD, MSc National and Kapodistrian University of Athens
Study Director: Argyrios Tsantes, MD, PhD National and Kapodistrian University of Athens
Study Chair: Iraklis Tsagkaris, MD, PhD National and Kapodistrian University of Athens
Study Chair: Apostolos Armaganidis, MD, PhD National and Kapodistrian University of Athens

Publications:
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Responsible Party: Eleni Vrigkou, PhD candidate, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03195543     History of Changes
Other Study ID Numbers: ΕΒΔ410/17-9-14
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eleni Vrigkou, National and Kapodistrian University of Athens:
Blood coagulation disorders
Platelets
Thrombin
Treatment
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Hemostatic Disorders
Blood Coagulation Disorders
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases
Hemorrhagic Disorders
Thrombin
Hemostatics
Coagulants