Effects of COPD and treatments on clot functionality.
Research type
Research Study
Full title
Effects of COPD and its underlying inflammatory response on coagulation and the effects of treatments including oxygen therapy and non-invasive ventilation as assessed by the biomarkers, fractal dimension and normal force- a feasibility study.
IRAS ID
327917
Contact name
Karl Hawkins
Contact email
Sponsor organisation
Swansea University
Clinicaltrials.gov Identifier
8293, Sponsor number
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory condition characterised by non-reversible airflow obstruction and impairment of gas exchange. COPD patients have a four-fold increased mortality from ischaemic heart disease and a quarter of patients develop pulmonary emboli. This is likely due to an increased systemic inflammatory response, dehydration and immobility. Recent study ha shown that in COPD patients, conventional coagulation biomarkers are ineffective in quantifying this thrombotic risk. Fractal dimension (df), is a biomarker of blood coagulation that quantifies the clot microstructure. Previous studies have demonstrated that high df indicates dense clot microstructure that is impermeable to thrombolysis and low df indicates loose and less compact clot microstructure that is easy to breakdown. Recent study showed that df was significantly elevated in COPD patients during acute exacerbation when compared to stable group. This indicates that during exacerbation COPD patients are thrombogenic. There are certain groups of COPD patients who receive supportive treatments including long term oxygen therapy and non-invasive ventilation. In addition, there are a group of COPD patients to whom oxygen is declined and these group of patients may have high red blood cell count which is called polycythaemia that causes increase in viscosity. Normal force (Fn) is a biomarker that reflects contractile forces of a blood clot. The aim of the study is to demonstrate whether the tendency of blood clot formation differs between these groups of patients utilizing the biomarkers fractal dimension and normal force. Patients aged 35 and above with a confirmed diagnosis of COPD as defined by GOLD criteria (Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 202) will be identified by the respiratory team and refer to research team. The study will be conducted in Welsh Centre for Emergency Medicine Research, Morriston hospital and the COPD patients are recruited from the respiratory clinic in Singleton Hospital. This feasibility study aim to recruit a total of 40 patients, 10 patients each in four groups; stable group, those on oxygen therapy, those on non-invasive ventilation and those who has been declined oxygen therapy. The findings from this study will inform a large adequately powered study.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0043
Date of REC Opinion
11 Apr 2024
REC opinion
Further Information Favourable Opinion