NCT01504867

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 13, 2016

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

3.7 years

First QC Date

January 3, 2012

Results QC Date

August 17, 2016

Last Update Submit

January 23, 2017

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress SyndromeAcute Lung InjuryARDSALIaspirinprevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within seven days from hospital presentation

Secondary Outcomes (6)

  • Hospital Mortality

    28 days

  • Number of Participants With ARDS or Mortality Within 7 Days

    within 7 days

  • Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization

    approximately 7 days

  • Mean Number of Days Participants Were Ventilator-Free To Day 28

    baseline, Day 28

  • Number of Subjects Admitted to Intensive Care Unit (ICU)

    7 days

  • +1 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

This group received matching lactose powder filled capsules on days 1-7.

Drug: Lactose powder

Interventions

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.

Aspirin
Lactose powderDRUG

Matching lactose powder filled capsules will be administered on days 1-7.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Stanford Univeristy

Stanford, California, 94305, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

University of Florida

Gainsville, Florida, 32610, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Louisville Medical Center

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 021114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Medical Center

Winston-Salem, North Carolina, 27517, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • 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.

    PMID: 27179988RESULT

  • 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.

    PMID: 29782179DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Daryl J. Kor
Organization
Mayo Clinic
Kor.Daryl@mayo.edu
507-284-7678

Study Officials

  • Daryl Kor, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 6, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 6, 2017

Results First Posted

October 13, 2016

Record last verified: 2017-01

Locations

US(16)