Phase 2
N=400
LIPS-A: Lung Injury Prevention Study With Aspirin
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01504867 ↗Enrolled (actual)
400
Serious AEs
3.1%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days — 20; 17 participants — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aspirin (Drug); Lactose powder (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days |
20; 17 | 0.53 |
| SECONDARY Hospital Mortality |
14; 14 | >0.99 |
| SECONDARY Number of Participants With ARDS or Mortality Within 7 Days |
27; 21 | 0.36 |
| SECONDARY Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization |
51; 41 | 0.23 |
| SECONDARY Mean Number of Days Participants Were Ventilator-Free To Day 28 |
24.9; 25.2 | 0.72 |
| SECONDARY Number of Subjects Admitted to Intensive Care Unit (ICU) |
115; 98 | 0.08 |
| SECONDARY Mean Hospital Length of Stay |
8.8; 9.0 | 0.79 |
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
- Previously enrolled in this trial
- Enrolled in a concomitant intervention trial
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01504867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.