Platelet Activation and Reactivity in Acute Exacerbations of COPD

• Conditions: COPD Exacerbation

• Registration Number: NCT03017625
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-12-12
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11
• Primary Completion: 2017-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• >40 years
• Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < 70% and less than 12% on reversibility testing< Lower limit of normal (LLN))
• ≥10 pack years of smoking

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Exclusion Criteria

• Use of anti-coagulation or other platelet function inhibitors
• Asthma
• Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
• Malignancies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.	Measured at presentation with an AE-COPD and after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Tissue factor triggered thrombin generation capacity	Measured at presentation with an AE-COPD and after 8 weeks
Platelet-monocyte interaction (CD14 cells positive for CD61)	Measured at presentation with an AE-COPD and after 8 weeks
Monocyte activation (CD11b expression on CD14 positive cells)	Measured at presentation with an AE-COPD and after 8 weeks
Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer	Measured at presentation with an AE-COPD and after 8 weeks