Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 1:55 PM
Study NCT ID:
NCT00164034
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma Reception and Resuscitation Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Error rate per patient treated demonstrated by deviation from the algorithms'}], 'secondaryOutcomes': [{'measure': 'Missed injuries'}, {'measure': 'Time to decision'}]}, 'conditionsModule': {'keywords': ['Trauma', 'Wounds', 'Injuries'], 'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '21339436', 'type': 'DERIVED', 'citation': "Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333."}], 'seeAlsoLinks': [{'url': 'http://www.ntri.org.au/', 'label': 'National Trauma Research Institute'}, {'url': 'http://www.alfred.org.au', 'label': 'The Alfred Hospital, Melbourne, Victoria, Australia.'}]}, 'descriptionModule': {'briefSummary': 'Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients.\n\nDemonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All injured patients \\> 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.\n\nExclusion Criteria: Stable Trauma patients (ie Pulse rate \\<100/minute, MAP \\>70mmHg, Hb \\>70, temperature \\>35 and \\<37.5, Spo2 \\>92%, GCS \\>13) undergoing secondary transfer from another hospital, where trauma occurred \\>6hrs prior to arrival.'}, 'identificationModule': {'nctId': 'NCT00164034', 'briefTitle': 'Trauma Reception and Resuscitation Project', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': "Trauma Reception and Resuscitation Project - 'Time for a New Approach'", 'orgStudyIdInfo': {'id': '166/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Real time computer prompted trauma algorithms', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital, Emergency and Trauma Centre, .', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Mark Fitzgerald, MBBS, FACEM, MRCMA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred Hospital, Bayside Health, Melbourne, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Victorian Trauma Foundation', 'class': 'OTHER'}, {'name': 'National Trauma Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}