Aspirin as a new treatment for a disease called ARDS

Phase 1

• Conditions: Acute respiratory distress syndrome; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-002564-32-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-04
• Study Completion: 2019-01-04
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1.Patients receiving invasive mechanical ventilation
2.ARDS as defined by the Berlin definition
a)Onset within 1 week of identified insult
b)Within the same 24 hour time period
i.Hypoxic respiratory failure (PaO2/ FiO2 ratio = 40kPa on PEEP = 5 cmH20)
ii.Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology
iii.No evidence of heart failure or volume overload

Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1.More than 72 hours from the onset of ARDS
2.Age < 16 years
3.Patient is known to be pregnant
4.Participation in a clinical trial of an investigational medicinal product within 30 days
5.Current treatment with aspirin or within the past 4 weeks
6.Platelet count < 50 x 109/l
7.Haemophilia or other haemorrhagic disorder or concurrent therapeutic anticoagulant therapy
8.History of aspirin sensitive asthma or nasal polyps associated with asthma
9.Active peptic ulcer disease or endoscopically proven history of peptic ulceration
10.Traumatic brain injury
11.Severe chronic liver disease with Child-Pugh score > 12
12.Active or recent bleeding (in previous 3 months)
13.Known hypersensitivity or previous adverse reaction to aspirin
14.Physician decision that aspirin is required for proven indication
15.Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction.
16.Treatment withdrawal imminent within 24 hours
17.Consent declined.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified