LIPS-A: Lung Injury Prevention Study With Aspirin

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Beth Israel Deaconess Medical Center; Montefiore Medical Center; National Center for Research Resources (NCRR); National Heart, Lung, and Blood Institute (NHLBI); Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Aspirin

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