Platelet Activation and Reactivity in Acute Exacerbations of COPD

Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)

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.

Study Overview

• Status: Unknown
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: Blood is drawn

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Floor E Aleva, MD; Phone Number: 0031 24 361 03 25; Email: floor.aleva@radboudumc.nl
• Study Contact Backup: Name: Yvonne F Heijdra, MD, PhD; Phone Number: 0031 24 361 03 25; Email: yvonne.heijdra@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria

Description

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Tissue factor triggered thrombin generation capacity	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Yvonne F Heijdra, Md, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Inflammation; COPD; Cardiovascular Disease; Platelets
• Other Study ID Numbers: 2016-2847