Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 8:29 AM
Study NCT ID:
NCT00517166
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2007-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survey of Tourniquet Use in a Combat Support Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-19', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-14', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-16', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tourniquet', 'extremity injury', 'hemostatic device'], 'conditions': ['Vascular Injury']}, 'referencesModule': {'references': [{'pmid': '22128725', 'type': 'DERIVED', 'citation': "Kragh JF Jr, O'Neill ML, Walters TJ, Jones JA, Baer DG, Gershman LK, Wade CE, Holcomb JB. Minor morbidity with emergency tourniquet use to stop bleeding in severe limb trauma: research, history, and reconciling advocates and abolitionists. Mil Med. 2011 Jul;176(7):817-23. doi: 10.7205/milmed-d-10-00417."}, {'pmid': '21455908', 'type': 'DERIVED', 'citation': "Kragh JF Jr, O'Neill ML, Beebe DF, Fox CJ, Beekley AC, Cain JS, Parsons DL, Mabry RL, Blackbourne LH. Survey of the indications for use of emergency tourniquets. J Spec Oper Med. 2011 Winter;11(1):30-34. doi: 10.55460/36SQ-1UQU."}, {'pmid': '19717268', 'type': 'DERIVED', 'citation': 'Kragh JF Jr, Littrel ML, Jones JA, Walters TJ, Baer DG, Wade CE, Holcomb JB. Battle casualty survival with emergency tourniquet use to stop limb bleeding. J Emerg Med. 2011 Dec;41(6):590-7. doi: 10.1016/j.jemermed.2009.07.022. Epub 2009 Aug 31.'}, {'pmid': '19106667', 'type': 'DERIVED', 'citation': 'Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Survival with emergency tourniquet use to stop bleeding in major limb trauma. Ann Surg. 2009 Jan;249(1):1-7. doi: 10.1097/SLA.0b013e31818842ba.'}]}, 'descriptionModule': {'briefSummary': 'Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected.', 'detailedDescription': 'This is a performance improvement project that is a prospective observational cohort design with subgroup analyses. This project meets the criteria of research with its intent to publish. No data is generated and only existing data are used. No interventions are made and the comparisons will be with within subgroups in the cohort.\n\nAim 1. Describe the number of tourniquets which were appropriately used (wound required a tourniquet and tourniquet was placed properly) as assessed by treating physician\n\nAim 2 \\&3. Describe if limbs wounds with tourniquets were bleeding upon admission, resuscitation, and following tourniquet removal\n\nAim 4. Describe if mortality for the cohort of patients with tourniquets is different than the mortality predicted by various injury scoring systems\n\nAim 5. Compare patient outcomes between those in which a tourniquet was indicated but not used and those for whom a tourniquet was indicated and used\n\nAim 6. Determine if patients that received tourniquets for an extended time period exhibit any known tourniquet complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Combat soldiers on whom tourniquet was applied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* penetrating extremity injury with tourniquet use\n\nExclusion Criteria:\n\n* non penetrating extremity injury'}, 'identificationModule': {'nctId': 'NCT00517166', 'briefTitle': 'Survey of Tourniquet Use in a Combat Support Hospital', 'organization': {'class': 'FED', 'fullName': 'United States Army Institute of Surgical Research'}, 'officialTitle': 'Survey of Tourniquet Use in a Combat Support Hospital', 'orgStudyIdInfo': {'id': 'IRAQ 06-010'}, 'secondaryIdInfos': [{'id': 'I.2006.175dt'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Individuals on whom tourniquet was used.', 'interventionNames': ['Device: CAT (Combat Arms Tourniquet)']}], 'interventions': [{'name': 'CAT (Combat Arms Tourniquet)', 'type': 'DEVICE', 'description': 'device', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Combat Support Hospital', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'John F Kragh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Army Institute of Surgical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Institute of Surgical Research', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}