LIPS-A: Lung Injury Prevention Study With Aspirin

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT01504867

Run by

Mayo Clinic

People needed

400

Starts

2012-01-01

Expected to finish

2015-09-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Univeristy — Stanford, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• University of Florida — Gainsville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Louisville Medical Center — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Medical Center — Winston-Salem, North Carolina, United States
• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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