Acute Respiratory Distress SyndromePhase 2NCT01504867
LIPS-A: Lung Injury Prevention Study With Aspirin
A Phase 2 study testing Aspirin and Lactose powder in people with Acute Respiratory Distress Syndrome, run by Mayo Clinic at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Aspirin and Lactose powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2012to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 021114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Bridgeport Hospital
Bridgeport, Connecticut, 06610
University of Illinois at Chicago
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainsville, Florida, 32610
Mayo Clinic in Florida
Jacksonville, Florida, 32224
University of Louisville Medical Center
Louisville, Kentucky, 40202
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Harborview Medical Center
Seattle, Washington, 98104
Stanford Univeristy
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27517
About this study
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.
Read the detailed description
Acute respiratory distress syndrome (ARDS) remains a life-threatening critical care syndrome characterized by alveolar-capillary membrane injury and hypoxemic respiratory failure. The median time to onset of ARDS is 2 days after hospital presentation. Therefore, the period between hospital presentation and the development of ARDS presents a brief window of opportunity for ARDS prevention.
This was a multicenter, double-blind, placebo-controlled, parallel-group, Phase 2b, randomized clinical trial. Development of ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission. The first dose of study drug or placebo was administered within 24 hours after presentation to the hospital. Important co-interventions were standardized across sites using a web-based tool, Checklist for Lung Injury Prevention. Study participants were screened daily for receipt of mechanical ventilation and determination of the partial pressure of arterial oxygen (PaO2) or oxygen saturation to fraction of inspired oxygen ratio (SpO2:FIO2). If the participant's SpO2:FIO2 ratio was consistently below 315, hypoxemia was confirmed with measurement of arterial blood gas. Chest radiographs for all intubated patients with a SpO2:FIO2 of 300 or less were independently reviewed by both site investigator and a member of the trial's executive committee. Study participants who died or were discharged from the hospital before day 7 without meeting criteria for ARDS were adjudicated as not having ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Aspirin, Lactose powder
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, ARDS, ALI, aspirin, prevention
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
325mg loading dose once on study day 1, followed by 81mg dose once daily on study days 2-7. Administered by mouth or down nasal gastric tube.
Lactose powderDrug
Matching lactose powder filled capsules will be administered on days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. Receives: Drug: Aspirin |
| Placebo | Placebo comparator | This group received matching lactose powder filled capsules on days 1-7. Receives: Drug: Lactose powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days
ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.
Measured: Within seven days from hospital presentation
Secondary outcomes (6)
Hospital Mortality
Measured: 28 days
Number of Participants With ARDS or Mortality Within 7 Days
Measured: within 7 days
Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization
Measured: approximately 7 days
Mean Number of Days Participants Were Ventilator-Free To Day 28
Measured: baseline, Day 28
Number of Subjects Admitted to Intensive Care Unit (ICU)
Measured: 7 days
Mean Hospital Length of Stay
Measured: approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Montefiore Medical Center, Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Daryl J. Kor, M.D., Mayo Clinic
- Investigators
- Daryl Kor, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504867
- Sponsor's protocol ID
- 10-004856
- Other IDs
- U01HL108712-01, KL2RR024151, K23HL112855, UL1TR000433
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2012
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27179988Abdulnour 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.
PubMed 29782179
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIPS-A: Lung Injury Prevention Study With Aspirin
- ClinicalTrials.gov ID
- NCT01504867
- Acronym / sponsor ID
- 10-004856
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, ARDS, ALI, aspirin, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Montefiore Medical Center, Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Study start
- Jan 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute respiratory distress syndrome (ARDS) remains a life-threatening critical care syndrome characterized by alveolar-capillary membrane injury and hypoxemic respiratory failure. The median time to onset of ARDS is 2 days after hospital presentation. Therefore, the period between hospital presentation and the development of ARDS presents a brief window of opportunity for ARDS prevention.
This was a multicenter, double-blind, placebo-controlled, parallel-group, Phase 2b, randomized clinical trial. Development of ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission. The first dose of study drug or placebo was administered within 24 hours after presentation to the hospital. Important co-interventions were standardized across sites using a web-based tool, Checklist for Lung Injury Prevention. Study participants were screened daily for receipt of mechanical ventilation and determination of the partial pressure of arterial oxygen (PaO2) or oxygen saturation to fraction of inspired oxygen ratio (SpO2:FIO2). If the participant's SpO2:FIO2 ratio was consistently below 315, hypoxemia was confirmed with measurement of arterial blood gas. Chest radiographs for all intubated patients with a SpO2:FIO2 of 300 or less were independently reviewed by both site investigator and a member of the trial's executive committee. Study participants who died or were discharged from the hospital before day 7 without meeting criteria for ARDS were adjudicated as not having ARDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinThis arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. |
| Placebo | Placebo comparator | Drug: Lactose powderThis group received matching lactose powder filled capsules on days 1-7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin325mg loading dose once on study day 1, followed by 81mg dose once daily on study days 2-7. Administered by mouth or down nasal gastric tube. | Drug | Aspirin |
| Lactose powderMatching lactose powder filled capsules will be administered on days 1-7. | Drug | Placebo |
Primary outcome
Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days
Time frame: Within seven days from hospital presentation
ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.
6 secondary outcomes
Hospital Mortality
Time frame: 28 days
Number of Participants With ARDS or Mortality Within 7 Days
Time frame: within 7 days
Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization
Time frame: approximately 7 days
Mean Number of Days Participants Were Ventilator-Free To Day 28
Time frame: baseline, Day 28
Number of Subjects Admitted to Intensive Care Unit (ICU)
Time frame: 7 days
Mean Hospital Length of Stay
Time frame: approximately 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27179988Kor 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.
- Derived from this study: PubMed 29782179Abdulnour 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryl Kor, MD principal investigator
Mayo Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin and Lactose powder in people with Acute Respiratory Distress Syndrome, run by Mayo Clinic at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days (time frame: Within seven days from hospital presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.