Pulmonary Artery HypertensionNCT03195543
Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension
An observational study of Pulmonary Artery Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Platelet function analyzer-100, Light transmission aggregometry and Rotational thromboelastometry
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 12 Mar 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Pulmonary Arterial Hypertension,
- Chronic Thromboembolic Pulmonary Hypertension.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon University Hospital
Athens, 12462
Eleni Vrigkou, MD, MSc, 0030-2105832179, elenivrigkou@gmail.com
Iraklis Tsagkaris, MD, PhD, 0030-2105832179, itsagkaris@med.uoa.gr
About this study
Official title: Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.
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.
Read the 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.
- Being tested
- Platelet function analyzer-100, Light transmission aggregometry, Rotational thromboelastometry, Endogenous thrombin potential
- Keywords
- Blood coagulation disorders, Platelets, Thrombin, Treatment
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet function analyzer-100Diagnostic test
Also called PFA-100
The PFA-100 system evaluates primary hemostasis in whole blood samples.
Light transmission aggregometryDiagnostic test
Light transmission aggregometry is the gold standard method for assessing platelet function.
Rotational thromboelastometryDiagnostic test
Also called ROTEM
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 potentialDiagnostic test
Also called ETP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Light transmission aggregometry; Diagnostic Test: Rotational thromboelastometry; Diagnostic 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. Receives: Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Light transmission aggregometry; Diagnostic Test: Rotational thromboelastometry; Diagnostic Test: Endogenous thrombin potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start12 Mar 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni Vrigkou, National and Kapodistrian University of Athens
- Investigators
- Eleni Vrigkou, MD, MSc, Principal investigator, National and Kapodistrian University of AthensArgyrios Tsantes, MD, PhD, Study director, National and Kapodistrian University of AthensIraklis Tsagkaris, MD, PhD, Study chair, National and Kapodistrian University of AthensApostolos Armaganidis, MD, PhD, Study chair, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195543
- Sponsor's protocol ID
- ΕΒΔ410/17-9-14
- Status last verified
- Mar 2019
- First submitted
- 8 Jun 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19697592Herve 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.
PubMed 11590840Lopes 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.
PubMed 12516685Preston 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.
PubMed 27747077Remkova 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.
PubMed 26309645Lang 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.
PubMed 27571003
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT03195543
- Acronym / sponsor ID
- ΕΒΔ410/17-9-14
- Keywords
- Blood coagulation disorders, Platelets, Thrombin, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PAH | – | Diagnostic Test: Platelet function analyzer-100, Diagnostic Test: Light transmission aggregometry, Diagnostic Test: Rotational thromboelastometry, Diagnostic Test: Endogenous thrombin potentialDiagnostic 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. |
| Patients with CTEPH | – | Diagnostic Test: Platelet function analyzer-100, Diagnostic Test: Light transmission aggregometry, Diagnostic Test: Rotational thromboelastometry, Diagnostic Test: Endogenous thrombin potentialDiagnostic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Pulmonary Arterial Hypertension,
- Chronic Thromboembolic Pulmonary Hypertension.
Key exclusion criteria (8 listed)
- renal insufficiency,
- hepatic insufficiency,
- thyroid dysfunction,
- malignancy,
- active infections,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet function analyzer-100Also: PFA-100The PFA-100 system evaluates primary hemostasis in whole blood samples. | Diagnostic test | Patients with CTEPH, Patients with PAH |
| Light transmission aggregometryLight transmission aggregometry is the gold standard method for assessing platelet function. | Diagnostic test | Patients with CTEPH, Patients with PAH |
| Rotational thromboelastometryAlso: ROTEMROTEM 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. | Diagnostic test | Patients with CTEPH, Patients with PAH |
| Endogenous thrombin potentialAlso: ETPThe 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. | Diagnostic test | Patients with CTEPH, Patients with PAH |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Background: PubMed 19697592Berger G, Azzam ZS, Hoffman R, Yigla M. Coagulation and anticoagulation in pulmonary arterial hypertension. Isr Med Assoc J. 2009 Jun;11(6):376-9.
- Background: PubMed 11590840Herve 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.
- Background: PubMed 12516685Lopes 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.
- Background: PubMed 27747077Preston 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.
- Background: PubMed 26309645Remkova 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.
- Background: PubMed 27571003Lang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Vrigkou, MD, MSc principal investigator
National and Kapodistrian University of Athens
Argyrios Tsantes, MD, PhD study director
National and Kapodistrian University of Athens
Iraklis Tsagkaris, MD, PhD study chair
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Vrigkou, MD, MSc (00302105832179, elenivrigkou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFA-100 in detection of platelet abnormalities in PAH and CTEPH patients. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195543, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.