LIPS-A: Lung Injury Prevention Study With Aspirin

Location:

Rochester, Minn., Jacksonville, Fla.

Trial status:
Open for Enrollment
Why is this study being done?

This is a multi-center, phase, phase II double-blind, placebo-controled, randomized trial of aspirin for the prevention of acute lung injury in patients identified as at risk for acute lung injury.

Who is eligible to participate?

Inclusion Criteria: - Adult patients (age > 18) admitted to the hospital through the emergency department (ED) - At high risk of developing 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 (NSAID's) - 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

Last updated:
3/17/2014
NCT ID:
NCT01504867
IRB Number:
10-004856