drugset / Trial / NCT01504867
LIPS-A: Lung Injury Prevention Study With Aspirin
Phase 2
Completed
400 enrolled
Mayo Clinic
Beth Israel Deaconess Medical Center · collabMontefiore Medical Center · collabNational Center for Research Resources (NCRR) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabVanderbilt University Medical Center · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2012-01
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Missed primary endpoint
registry Aspirin vs Placebo; p = 0.53; Wald NCT01504867 ↗
paper Administration of aspirin, compared with placebo, did not significantly reduce the incidence of ARDS at 7 days PMID 27179988 ↗
Publications
- Results Kor DJ, Carter RE, Park PK, Festic E, Banner-Goodspeed VM, Hinds R, Talmor D, Gajic O, Ware LB, Gong MN; US Critical Illness and Injury Trials Group: Lung Injury Prevention with Aspirin Study Group (USCIITG: LIPS-A). Effect of Aspirin on Development of ARDS in At-Risk Patients Presenting to the Emergency Department: The LIPS-A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2406-14. doi: 10.1001/jama.2016.6330.
- Abdulnour RE, Gunderson T, Barkas I, Timmons JY, Barnig C, Gong M, Kor DJ, Gajic O, Talmor D, Carter RE, Levy BD. Early Intravascular Events Are Associated with Development of Acute Respiratory Distress Syndrome. A Substudy of the LIPS-A Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1575-1585. doi: 10.1164/rccm.201712-2530OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | Oral |