LIPS-A: Lung Injury Prevention Study with Aspirin

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Jacksonville, Florida: 10-004856
    • Rochester, Minnesota: 10-004856
  • NCT ID:

  • Sponsor Protocol Number:


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Daryl Kor, M.D.

Closed for enrollment

Estela Staggs B.S.N., R.N., CCRP

Rochester, Minn.

Mayo Clinic principal investigator

Daryl Kor, M.D.

Closed for enrollment

Clinical Studies Unit

(904) 953-2255