The Coagulation Cascade in Idiopathic Pulmonary Fibrosis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced as a result and is over expressed in IPF patients, so may be important in propagating disease activity. We aim to recruit patients with IPF and then complete FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans pre and post manipulation of the coagulation cascade to assess the role of this biological pathway in disease activity. Previous studies from our institution have demonstrated increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to date the cells and pathways responsible for this signal have not been identified and thus need further exploration.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• A diagnosis of IPF based on multi disciplinary meeting discussion following review of the clinical history, characteristic features on HRCT (high resolution CT scan) and/or usual interstitial pneumonia (UIP) histology.

• Written informed consent obtained from subject.

Exclusion Criteria:

• Age <40 or >80 years

• Renal impairment as defined by a creatinine clearance of <30 millilitres/min

• Significant liver impairment with evidence of synthetic dysfunction

• Any contraindication to anti-coagulation including previous life threatening or serious bleed or bleeding tendency.

• Co-administration of any concomitant medications prohibited in full protocol. N-acetyl cysteine, prednisolone up to 10mg daily and pirfenidone are permitted.

• Pregnant, breast feeding or unwilling to practice birth control during participation in the study (females of child bearing age).

• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient of the quality of the data.