Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195543
• Other study ID #: ???410/17-9-14
• Status: Recruiting
• Start date: March 12, 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: National and Kapodistrian University of Athens
• Contact: Eleni Vrigkou, MD, MSc
• Phone: 00302105832179
• Email: elenivrigkou[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 pulmonary hypertension- specific therapy may have on hemostasis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Chronic Thromboembolic Pulmonary Hypertension
• Hemostatic Disorders
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Artery Hypertension

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & 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. Review. — View Citation

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. Review. — View Citation

Lang IM, Dorfmüller 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. Review. — View Citation

Lopes AA, Caramurú LH, Maeda NY. Endothelial dysfunction associated with chronic intravascular coagulation in secondary pulmonary hypertension. Clin Appl Thromb Hemost. 2002 Oct;8(4):353-8. — View Citation

Preston IR, Farber HW. Anti-coagulation in pulmonary arterial hypertension: the real blood and guts. J Thorac Dis. 2016 Sep;8(9):E1106-E1107. — View Citation

Remková A, Šimková I, Valkovicová T. Platelet abnormalities in chronic thromboembolic pulmonary hypertension. Int J Clin Exp Med. 2015 Jun 15;8(6):9700-7. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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