Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT02326350
Eligibility Criteria:
Inclusion Criteria:
1. Patients receiving invasive mechanical ventilation.
2. ARDS as defined by the Berlin definition.
* Onset within 1 week of identified insult.
* Within the same 24 hours
* Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 40kPa on PEEP ≥ 5 cmH20),
* Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology,
* No evidence of heart failure or volume overload
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 or history of recurrent peptic ulcer and/ or gastric/ intestinal haemorrhage or other kinds of bleeding such as cerebrovascular haemorrhage.
10. Traumatic brain injury.
11. Active gout.
12. Currently receiving methotrexate.
13. Severe chronic liver disease with Child-Pugh score \> 12.
14. Known hypersensitivity or previous adverse reaction to salicylic acid compounds or prostaglandin synthetase inhibitors.
15. Physician decision that aspirin is required for proven indication.
16. Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction.
17. Treatment withdrawal imminent within 24 hours.
18. Consent declined.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02326350
Study Brief:
Protocol Section:
NCT02326350