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

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ClinicalTrials.gov Identifier: NCT02326350
Recruitment Status : Terminated (Slow recruitment)
First Posted : December 29, 2014
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Queen's University, Belfast
Northern Ireland Clinical Trials Unit
Information provided by (Responsible Party):
Professor Danny McAuley, Belfast Health and Social Care Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: Aspirin 75mg Drug: Lactose powder Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASpirin as a Treatment for ARDS (STAR): a Phase 2 Randomised Control Trial
Actual Study Start Date : February 6, 2015
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 23, 2018


Arm Intervention/treatment
Experimental: Aspirin 75mg
Aspirin 75mg enterally once daily for a maximum of 14 days
Drug: Aspirin 75mg
Active treatment

Placebo Comparator: Placebo
Lactose powder placebo enterally once daily for a maximum of 14 days
Drug: Lactose powder
Placebo




Primary Outcome Measures :
  1. Oxygenation index (OI) [ Time Frame: Day 7 ]
    OI is a physiological index of the severity of ARDS and measures both impaired oxygenation and the amount of mechanical ventilation delivered.


Secondary Outcome Measures :
  1. Oxygenation index [ Time Frame: Days 4 and 14 ]
  2. Sequential organ failure assessment (SOFA) score [ Time Frame: Days 4, 7 and 14 ]
    SOFA score is a measure of organ failure

  3. Respiratory compliance (Crs) [ Time Frame: Days 4, 7 and 14 ]
    Crs is a physiological measure of pulmonary function in ARDS

  4. Partial pressure of arterial oxygen to the fraction of inspired oxygen ratio (P/F ratio) [ Time Frame: Days 4, 7 and 14 ]
    P/F ratio is a physiological measure of pulmonary function in ARDS

  5. Safety and tolerability as assessed by the occurrence of serious adverse events and suspected unexpected serious adverse reactions [ Time Frame: Up to 28 days after completion of study drug ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326350


Sponsors and Collaborators
Belfast Health and Social Care Trust
Queen's University, Belfast
Northern Ireland Clinical Trials Unit
Investigators
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Principal Investigator: Danny F McAuley, Professor Belfast Health and Social Care Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Danny McAuley, Professor and consultant of Intensive Care Medicine, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT02326350     History of Changes
Other Study ID Numbers: 14043DMcA-AS
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Professor Danny McAuley, Belfast Health and Social Care Trust:
Acute Respiratory Distress syndrome
Aspirin

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics