NCT03195543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

5.7 years

First QC Date

June 8, 2017

Last Update Submit

March 21, 2019

Conditions

Pulmonary Artery HypertensionChronic Thromboembolic Pulmonary Hypertension

Keywords

Blood coagulation disordersPlateletsThrombinTreatment

Outcome Measures

Primary Outcomes (4)

  • PFA-100 in detection of platelet abnormalities in PAH and CTEPH patients.

    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.

    6 months

  • Light transmission aggreggometry in detection of platelet abnormalities in PAH and CTEPH patients.

    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.

    6 months

  • ROTEM in detection of coagulation abnormalities in PAH and CTEPH patients.

    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.

    6 months

  • Endogenous thrombin potential in detection of thrombin abnormalities in PAH and CTEPH patients.

    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.

    6 months

Study Arms (2)

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-100Diagnostic Test: Light transmission aggregometryDiagnostic Test: Rotational thromboelastometryDiagnostic Test: Endogenous thrombin potential

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-100Diagnostic Test: Light transmission aggregometryDiagnostic Test: Rotational thromboelastometryDiagnostic Test: Endogenous thrombin potential

Interventions

Platelet function analyzer-100DIAGNOSTIC_TEST

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

Also known as: PFA-100
Patients with CTEPHPatients with PAH
Light transmission aggregometryDIAGNOSTIC_TEST

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

Patients with CTEPHPatients with PAH
Rotational thromboelastometryDIAGNOSTIC_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.

Also known as: ROTEM
Patients with CTEPHPatients with PAH
Endogenous thrombin potentialDIAGNOSTIC_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.

Also known as: ETP
Patients with CTEPHPatients with PAH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Pulmonary Arterial Hypertension,
  • Chronic Thromboembolic Pulmonary Hypertension.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon University Hospital

Athens, 12462, Greece

RECRUITING

Related Publications (6)

  • 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.

    PMID: 19697592BACKGROUND

  • 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.

    PMID: 11590840BACKGROUND

  • 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.

    PMID: 12516685BACKGROUND

  • 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.

    PMID: 27747077BACKGROUND

  • 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.

    PMID: 26309645BACKGROUND

  • 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.

    PMID: 27571003BACKGROUND

MeSH Terms

Conditions

Familial Primary Pulmonary HypertensionBlood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Eleni Vrigkou, MD, MSc

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

  • Argyrios Tsantes, MD, PhD

    National and Kapodistrian University of Athens

    STUDY DIRECTOR

  • Iraklis Tsagkaris, MD, PhD

    National and Kapodistrian University of Athens

    STUDY CHAIR

  • Apostolos Armaganidis, MD, PhD

    National and Kapodistrian University of Athens

    STUDY CHAIR

Central Study Contacts

Eleni Vrigkou, MD, MSc

CONTACT

00302105832179elenivrigkou@gmail.com

Argyrios Tsantes, MD, PhD

CONTACT

00302105830000atsantes@med.uoa.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 22, 2017

Study Start

March 12, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)