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LIPS-A: Lung Injury Prevention Study With Aspirin

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ClinicalTrials.gov Identifier: NCT01504867
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : October 13, 2016
Last Update Posted : March 6, 2017
Sponsor:
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)
Information provided by (Responsible Party):
Daryl J. Kor, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 6, 2012
Results First Submitted Date  ICMJE August 17, 2016
Results First Posted Date  ICMJE October 13, 2016
Last Update Posted Date March 6, 2017
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Development of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Within seven days from hospital presentation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
  • Hospital Mortality [ Time Frame: 28 days ]
  • Lung Injury Score [ Time Frame: 7 days ]
  • Barthel Index [ Time Frame: 6 and 12 months ]
  • SF 12 [ Time Frame: 6 and 12 Month ]
    quality of life survey
  • Organ failure free days [ Time Frame: To day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LIPS-A: Lung Injury Prevention Study With Aspirin
Official Title  ICMJE LIPS-A: Lung Injury Prevention Study With Aspirin
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • 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.
  • Drug: Lactose powder
    Matching lactose powder filled capsules will be administered on days 1-7.
Study Arms  ICMJE
  • Experimental: Aspirin
    This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo
    This group received matching lactose powder filled capsules on days 1-7.
    Intervention: Drug: Lactose powder
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2012)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504867
Other Study ID Numbers  ICMJE 10-004856
U01HL108712-01 ( U.S. NIH Grant/Contract )
KL2RR024151 ( U.S. NIH Grant/Contract )
K23HL112855 ( U.S. NIH Grant/Contract )
UL1TR000433 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Daryl J. Kor, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • 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)
Investigators  ICMJE
Principal Investigator: Daryl Kor, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP