LIPS-A: Lung Injury Prevention Study With Aspirin
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Intervention: Aspirin; Lactose powder
Intervention description: 325mg loading dose once on study day 1, followed by 81mg dose once daily on study days 2-7. Administered by mouth or down nasal gastric tube.; Matching lactose powder filled capsules will be administered on days 1-7.
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury; ARDS; ALI; aspirin; prevention

Summary:

      The primary hypothesis was that early aspirin administration will decrease the rate of
      developing acute lung injury during the first 7 days after presentation to the hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (age > 18) admitted to the hospital through the emergency department
             (ED)

          -  At high risk of developing acute lung injury (ALI) Lung Injury Prediction Score (LIPS)
             greater than or equal to 4

        Exclusion Criteria:

          -  Anti-platelet therapy on admission or within 7 days prior to admission

          -  Presented to outside hospital ED > 12 hrs before arrival at site's facility

          -  Inability to obtain consent within 12 hours of hospital presentation

          -  Admitted for elective surgery

          -  Acute lung injury prior to randomization

          -  Receiving mechanical ventilation through a tracheostomy tube prior to current hospital
             admission (patient who is ventilator dependent)

          -  Presence of bilateral pulmonary infiltrates on admission if he or she has a history of
             bilateral pulmonary infiltrates (as evidenced by previous x-rays) that can reasonably
             explain the current degree of pulmonary infiltrates present.

          -  Presentation due to pure heart failure and no other known risk factors for ALI.

          -  Allergy to aspirin or non steroidal anti inflammatory drugs (NSAIDs)

          -  Bleeding disorder

          -  Suspected active bleeding or judged to be at high risk for bleeding

          -  Active peptic ulcer disease (within past 6 months)

          -  Severe chronic liver disease

          -  Inability to administer the study drug

          -  Expected hospital stay < 48 hours

          -  Admitted for comfort or hospice care

          -  Patient, surrogate or physician not committed to full support. (Exception: a patient
             will not be excluded if he/she would receive all supportive care except for attempts
             at resuscitation from cardiac arrest)

          -  Not anticipated to survive > 48 hours

          -  Previously enrolled in this trial

          -  Enrolled in a concomitant intervention trial

          -  Pregnant or breastfeeding