Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension

NCT ID: NCT03195543

Last Updated: 2019-03-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-12

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

The PFA-100 system evaluates primary hemostasis in whole blood samples.

Light transmission aggregometry

Intervention Type DIAGNOSTIC_TEST

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

Rotational thromboelastometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

The PFA-100 system evaluates primary hemostasis in whole blood samples.

Light transmission aggregometry

Intervention Type DIAGNOSTIC_TEST

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

Rotational thromboelastometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Light transmission aggregometry

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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PFA-100 ROTEM ETP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Eleni Vrigkou

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Eleni Vrigkou, MD, MSc

Role: CONTACT

00302105832179

Argyrios Tsantes, MD, PhD

Role: CONTACT

00302105830000

Facility Contacts

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Eleni Vrigkou, MD, MSc

Role: primary

0030-2105832179

Iraklis Tsagkaris, MD, PhD

Role: backup

0030-2105832179

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.

Reference Type BACKGROUND
PMID: 19697592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11590840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12516685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27747077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26309645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27571003 (View on PubMed)

Other Identifiers

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ΕΒΔ410/17-9-14

Identifier Type: -

Identifier Source: org_study_id

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