Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 3:39 PM
Study NCT ID:
NCT01304433
Status:
COMPLETED
Last Update Posted:
2011-10-28
First Post:
2011-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Profile of Hydroxyethyl Starch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of adverse drug reactions', 'timeFrame': 'up to 48 hours'}], 'secondaryOutcomes': [{'measure': 'change in haemodynamics during surgery or intensive care unit stay', 'timeFrame': 'up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plasma Volume Replacement']}, 'descriptionModule': {'briefSummary': 'The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* patients with ASA risk score ≤ III,\n* non-emergency patients, i.e. elective surgery\n\nExclusion:\n\n* contraindications as listed for HES 130/0.42'}, 'identificationModule': {'nctId': 'NCT01304433', 'briefTitle': 'Safety Profile of Hydroxyethyl Starch', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42', 'orgStudyIdInfo': {'id': 'HC-O-H-0811'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'hydroxyethyl starch (HES) 130/0.42', 'interventionNames': ['Drug: Venofundin 6% / Tetraspan 6%']}], 'interventions': [{'name': 'Venofundin 6% / Tetraspan 6%', 'type': 'DRUG', 'description': 'Venofundin 6% / Tetraspan 6%', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xuzhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '210029', 'city': 'Nanjing, Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'The Sixth Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'country': 'China', 'facility': 'The First Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200438', 'city': 'Shanghai', 'country': 'China', 'facility': 'Dong Fang Gan Dan Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '50586', 'city': 'Kuala Lumpur', 'state': 'Malaysia', 'country': 'Malaysia', 'facility': 'Hospital Kuala Lumpur', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}