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LIPS-A: Lung Injury Prevention Study With Aspirin

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Daryl J. Kor, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01504867
First received: January 3, 2012
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Acute Respiratory Distress Syndrome
Drug: Aspirin
Drug: Lactose powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LIPS-A: Lung Injury Prevention Study With Aspirin

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days [ Time Frame: Within seven days from hospital presentation ] [ Designated as safety issue: No ]
    ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.


Secondary Outcome Measures:
  • Hospital Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With ARDS or Mortality Within 7 Days [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization [ Time Frame: approximately 7 days ] [ Designated as safety issue: No ]
  • Mean Number of Subjects Who Were Ventilator-Free To Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Number of Subjects Admitted to Intensive Care Unit (ICU) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Mean Hospital Length of Stay [ Time Frame: approximately 7 days ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: January 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
Drug: Aspirin
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.
Placebo Comparator: Placebo
This group received matching lactose powder filled capsules on days 1-7.
Drug: Lactose powder
Matching lactose powder filled capsules will be administered on days 1-7.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504867

Locations
United States, California
Stanford Univeristy
Stanford, California, United States, 94305
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Louisville Medical Center
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 021114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Medical Center
Winston Salem, North Carolina, United States, 27517
United States, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Mayo Clinic
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Daryl Kor, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Daryl J. Kor, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01504867     History of Changes
Other Study ID Numbers: 10-004856  U01HL108712-01  KL2RR024151  K23HL112855  UL1TR000433 
Study First Received: January 3, 2012
Results First Received: August 17, 2016
Last Updated: August 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Mayo Clinic:
Acute Respiratory Distress Syndrome
Acute Lung Injury
ARDS
ALI
aspirin
prevention

Additional relevant MeSH terms:
Aspirin
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on December 02, 2016