Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01504867
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2012-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
LIPS-A: Lung Injury Prevention Study With Aspirin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kor.Daryl@mayo.edu', 'phone': '507-284-7678', 'title': 'Dr. Daryl J. Kor', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.', 'otherNumAtRisk': 195, 'otherNumAffected': 13, 'seriousNumAtRisk': 195, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.', 'otherNumAtRisk': 195, 'otherNumAffected': 5, 'seriousNumAtRisk': 195, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NSTEMI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Hip Resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure Requiring Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding Stress Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia due to Upper GI Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia/Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulseless Electrical Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%', 'statisticalMethod': 'Wald', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within seven days from hospital presentation', 'description': 'ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ARDS or Mortality Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 7 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days Participants Were Ventilator-Free To Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, Day 28', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Admitted to Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Mean Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'approximately 7 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Inclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Consent revoked', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited between 1/2/2012 and 11/17/2014 at multiple US academic hospitals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'BG000', 'lowerLimit': '44.0', 'upperLimit': '67.0'}, {'value': '57.0', 'groupId': 'BG001', 'lowerLimit': '47.0', 'upperLimit': '68.0'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '400 subjects were randomized, and 10 subjects were excluded, leaving 390 in the final modified intention-to-treat analysis cohort.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2012-01-03', 'resultsFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-17', 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days', 'timeFrame': 'Within seven days from hospital presentation', 'description': 'ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.'}], 'secondaryOutcomes': [{'measure': 'Hospital Mortality', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With ARDS or Mortality Within 7 Days', 'timeFrame': 'within 7 days'}, {'measure': 'Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization', 'timeFrame': 'approximately 7 days'}, {'measure': 'Mean Number of Days Participants Were Ventilator-Free To Day 28', 'timeFrame': 'baseline, Day 28'}, {'measure': 'Number of Subjects Admitted to Intensive Care Unit (ICU)', 'timeFrame': '7 days'}, {'measure': 'Mean Hospital Length of Stay', 'timeFrame': 'approximately 7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress Syndrome', 'Acute Lung Injury', 'ARDS', 'ALI', 'aspirin', 'prevention'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '27179988', 'type': 'RESULT', 'citation': 'Kor DJ, Carter RE, Park PK, Festic E, Banner-Goodspeed VM, Hinds R, Talmor D, Gajic O, Ware LB, Gong MN; US Critical Illness and Injury Trials Group: Lung Injury Prevention with Aspirin Study Group (USCIITG: LIPS-A). Effect of Aspirin on Development of ARDS in At-Risk Patients Presenting to the Emergency Department: The LIPS-A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2406-14. doi: 10.1001/jama.2016.6330.'}, {'pmid': '29782179', 'type': 'DERIVED', 'citation': 'Abdulnour RE, Gunderson T, Barkas I, Timmons JY, Barnig C, Gong M, Kor DJ, Gajic O, Talmor D, Carter RE, Levy BD. Early Intravascular Events Are Associated with Development of Acute Respiratory Distress Syndrome. A Substudy of the LIPS-A Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1575-1585. doi: 10.1164/rccm.201712-2530OC.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (age \\> 18) admitted to the hospital through the emergency department (ED)\n* At high risk of developing acute lung injury (ALI) Lung Injury Prediction Score (LIPS) greater than or equal to 4\n\nExclusion Criteria:\n\n* Anti-platelet therapy on admission or within 7 days prior to admission\n* Presented to outside hospital ED \\> 12 hrs before arrival at site's facility\n* Inability to obtain consent within 12 hours of hospital presentation\n* Admitted for elective surgery\n* Acute lung injury prior to randomization\n* Receiving mechanical ventilation through a tracheostomy tube prior to current hospital admission (patient who is ventilator dependent)\n* 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.\n* Presentation due to pure heart failure and no other known risk factors for ALI.\n* Allergy to aspirin or non steroidal anti inflammatory drugs (NSAIDs)\n* Bleeding disorder\n* Suspected active bleeding or judged to be at high risk for bleeding\n* Active peptic ulcer disease (within past 6 months)\n* Severe chronic liver disease\n* Inability to administer the study drug\n* Expected hospital stay \\< 48 hours\n* Admitted for comfort or hospice care\n* 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)\n* Not anticipated to survive \\> 48 hours\n* Previously enrolled in this trial\n* Enrolled in a concomitant intervention trial\n* Pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT01504867', 'briefTitle': 'LIPS-A: Lung Injury Prevention Study With Aspirin', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'LIPS-A: Lung Injury Prevention Study With Aspirin', 'orgStudyIdInfo': {'id': '10-004856'}, 'secondaryIdInfos': [{'id': 'U01HL108712-01', 'link': 'https://reporter.nih.gov/quickSearch/U01HL108712-01', 'type': 'NIH'}, {'id': 'KL2RR024151', 'link': 'https://reporter.nih.gov/quickSearch/KL2RR024151', 'type': 'NIH'}, {'id': 'K23HL112855', 'link': 'https://reporter.nih.gov/quickSearch/K23HL112855', 'type': 'NIH'}, {'id': 'UL1TR000433', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000433', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin', 'description': 'This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.', 'interventionNames': ['Drug: Aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This group received matching lactose powder filled capsules on days 1-7.', 'interventionNames': ['Drug: Lactose powder']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Aspirin']}, {'name': 'Lactose powder', 'type': 'DRUG', 'description': 'Matching lactose powder filled capsules will be administered on days 1-7.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Univeristy', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '32610', 'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida'}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Medical Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '021114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27517', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Daryl Kor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Daryl J. Kor, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}