Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT01594034
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006465', 'term': 'Hemoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '•Establish a method for reliably measuring CO excretion in patients.', 'timeFrame': '96 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemoperitoneum']}, 'descriptionModule': {'briefSummary': 'Our objective is to determine whether or not the presence of hemoperitoneum in trauma patients is associated with increased Carbon Monoxide (CO) formation, and to determine if elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired platelet aggregation, and/or multiple organ failure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients in the ICU on a ventilator', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized males 18 years of age or older,\n2. Diagnosis of isolated blunt OR blunt and penetrating trauma,\n3. Admitted or expecting to be admitted to the Intensive Care Unit,\n4. On mechanical ventilation, and\n5. Written informed consent obtained\n\nExclusion Criteria:\n\n1. Female gender, (Females will be excluded from this study as the menstrual cycle and other estrogen variations are known to be associated with cyclic changes in CO production adding a potential confounder to the interpretations of our findings.)\n2. Diagnosis of isolated penetrating trauma,\n3. Acute hemothorax or pneumothorax,\n4. Treatment with antiaggregants (ASA, clopidogrel, aggrenox or ticlopidine),\n5. Enrollment in another research study,\n6. Prisoners,\n7. Inability to perform CO measurement within 96 hours after hospital admission.'}, 'identificationModule': {'nctId': 'NCT01594034', 'briefTitle': 'Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability', 'orgStudyIdInfo': {'id': 'HSC-2009-0176-H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no treatment', 'interventionNames': ['Procedure: expired air']}], 'interventions': [{'name': 'expired air', 'type': 'PROCEDURE', 'description': 'collection of expired air from ventilator', 'armGroupLabels': ['no treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert Johnson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}