ASpirin as a Treatment for ARDS (STAR): a Phase 2 Randomised Control Trial

• Status: Terminated
• Trial end date: 2018-11-23
• Target enrollment: 0
• Participant gender: All

Summary

Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through their inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. Blood cells called platelets have increasingly been recognized to play a key role in the development of ARDS. There is increasing information that aspirin, a drug which is widely used to treat heart disease, might be important in treating ARDS. We plan to test if aspirin will help in the treatment of ARDS. To do this we will divide patients suffering from ARDS into two groups, one of which will get aspirin and the other a harmless dummy (or placebo) tablet who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if aspirin is effective in patients with ARDS. This project will also provide new information about mechanisms in the development of ARDS leading, potentially, to other new treatments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belfast Health and Social Care Trust
• Collaborators: Northern Ireland Clinical Trials Unit; Queen's University, Belfast
• Treatments: Aspirin

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.