LIPS-A: Lung Injury Prevention Study With Aspirin

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

LIPS-A: Lung Injury Prevention Study With Aspirin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01504867
• Other study ID #: 10-004856
• Status: Recruiting
• Phase: Phase 2
• First received: January 3, 2012
• Last updated: November 17, 2014
• Start date: January 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• Lactose powder
Matching Lactulose powder filled capsules will be administered on days 1-7.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Montefiore Medical Center	Bronx	New York
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainsville	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	University of Louisville Medical Center	Louisville	Kentucky
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Harborview Medical Center	Seattle	Washington
United States	Stanford Univeristy	Stanford	California
United States	Wake Forest University Medical Center	Winston Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Ognjen Gajic	Beth Israel Deaconess Medical Center, Montefiore Medical Center, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Acute Respiratory Distress Syndrome (ARDS)		Within seven days from hospital presentation	No
Secondary	Hospital mortality		28 days	No
Secondary	Lung Injury Score		7 days	No
Secondary	Barthel Index		6 and 12 months	No
Secondary	SF 12	quality of life survey	6 and 12 Month	No
Secondary	Organ failure free days		To day 28	No