Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 5:44 AM
Study NCT ID:
NCT00870766
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Tomography (CT) Trial of Acute Abdomen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}], 'ancestors': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-13', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'at discharge and/or 2-3 mo follow-up'}]}, 'conditionsModule': {'conditions': ['Acute Abdomen']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* abdominal pain \\> 2h and \\< 7 days\n\nExclusion Criteria:\n\n* pregnancy\n* acute abdominal trauma\n* allergy to iodinated contrast media\n* severe renal insufficiency\n* metformin medication combined with elevated plasma creatinin level\n* lack of cooperation (if informed consent is not possible)\n* abdominal pain combined with bleeding shock'}, 'identificationModule': {'nctId': 'NCT00870766', 'acronym': 'PRACTA', 'briefTitle': 'Computer Tomography (CT) Trial of Acute Abdomen', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'orgStudyIdInfo': {'id': 'KUH5200617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CT', 'description': 'All patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER.', 'interventionNames': ['Procedure: Abdominal contrast-enhanced CT scanning']}, {'type': 'NO_INTERVENTION', 'label': 'Current practice', 'description': 'The patients in the current practice arm are referred to radiological examinations, such as US, plain radiography or CT, based on the clinical need only.'}], 'interventions': [{'name': 'Abdominal contrast-enhanced CT scanning', 'type': 'PROCEDURE', 'description': 'Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning', 'armGroupLabels': ['CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pekka Miettinen', 'oldOrganization': 'Kuopio University Hospital'}}}}