LIPS-A: Lung Injury Prevention Study With Aspirin

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Vanderbilt University
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01504867
First received: January 3, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This is a multi-center, phase, phase II double-blind, placebo-controled, randomized trial of aspirin for the prevention of acute lung injury in patients identified as at risk for acute lung injury.


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:
  • Development of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Within seven days from hospital presentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Lung Injury Score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • SF 12 [ Time Frame: 6 and 12 Month ] [ Designated as safety issue: No ]
    quality of life survey

  • Organ failure free days [ Time Frame: To day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
This arm will receive 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.
Sham Comparator: Placebo
This group will receive a placebo on days 1-7.
Drug: Lactose powder
Matching Lactulose powder filled capsules will be administered on days 1-7.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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 (NSAID's)
  • 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 Not yet recruiting
Stanford, California, United States, 94305
Contact: Rosemary Vojnik    650-723-7409    rvojnik@stanford.edu   
Principal Investigator: Joseph Levitt, M.D.         
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Diane Eannotti       ndeann@bpthosp.org   
Principal Investigator: David Kaufman, MD         
United States, Florida
University of Florida Recruiting
Gainsville, Florida, United States, 32610
Contact: Kelly Jackman, PhD    352-265-5911    jackman@ufl.edu   
Principal Investigator: Marie-Carmelle Elie, MD         
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kellie Ruday, RRT    904-953-2255    ruday.kellie@mayo.edu   
Principal Investigator: Emir Festic, MD         
United States, Illinois
University of Illinois at Chicago Terminated
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Louisville Medical Center Completed
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Valerie Banner-Goodspeed    617-754-3257    vgoodspe@bidmc.harvard.edu   
Principal Investigator: Daniel Talmor, MD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 021114
Contact: Mamary Kone, MD       MKONE@PARTNERS.ORG   
Principal Investigator: Edwin Bajwa, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Siddharth Parmar    617-732-5640    SPARMAR@partners.org   
Principal Investigator: Peter Hou, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kristine Brierly    734-936-5823    kbrier@med.umich.edu   
Principal Investigator: Pauline Park, MD         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Richard Hinds, MS    507-538-4344    hinds.richard@mayo.edu   
Principal Investigator: Daryl Kor, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Mirian Martinez    718-920-2956    MIRIMART@montefiore.org   
Principal Investigator: Michelle Gong, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Weiying Drake    919-681-0907    weiying.gao@duke.edu   
Principal Investigator: Ian Welsby, MD         
Wake Forest University Medical Center Recruiting
Winston Salem, North Carolina, United States, 27517
Contact: Bill Martin    336-716-6287    wmartin@wfubmc.edu   
Principal Investigator: Jason Hoth, MD         
United States, Pennsylvania
Temple University School of Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, M.D.    215-707-8402    nina.gentile@tuhs.temple.edu   
Principal Investigator: Nina Gentile, M.D.         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Laurie Al-Naser, RN    206-774-8965    lalnaser@medicine.washington.edu   
Principal Investigator: Tim Walkins, MD         
Sponsors and Collaborators
Ognjen Gajic
Beth Israel Deaconess Medical Center
Montefiore Medical Center
Vanderbilt University
Investigators
Principal Investigator: Daryl Kor, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Ognjen Gajic, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01504867     History of Changes
Other Study ID Numbers: 10-004856
Study First Received: January 3, 2012
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014