LIPS-A: Lung Injury Prevention Study With Aspirin
This study is currently recruiting participants.
Verified April 2013 by Mayo Clinic
Sponsor:
Ognjen Gajic
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: April 28, 2013
Last verified: April 2013
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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: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (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
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 | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Diane Delong 502-852-2604 dedelo01@gwise.louisville.edu | |
| Principal Investigator: Ozan Akca, MD | |
| 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: | April 28, 2013 |
| 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:
|
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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013