Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 9:40 PM
Study NCT ID:
NCT00806533
Status:
COMPLETED
Last Update Posted:
2009-05-19
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-15', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of adverse events', 'timeFrame': 'peri-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '18647272', 'type': 'BACKGROUND', 'citation': 'Sumpelmann R, Kretz FJ, Gabler R, Luntzer R, Baroncini S, Osterkorn D, Haeger MC, Osthaus WA. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). Paediatr Anaesth. 2008 Oct;18(10):929-33. doi: 10.1111/j.1460-9592.2008.02696.x. Epub 2008 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'paediatric patients aged up to 12 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤12 years\n* Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III\n* infusion of Venofundin 6% or of Tetraspan 6%\n* elective intervention\n\nExclusion Criteria:\n\n* contraindications according to SmPC'}, 'identificationModule': {'nctId': 'NCT00806533', 'briefTitle': 'Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years', 'orgStudyIdInfo': {'id': 'HC-O-H-0509'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HES 130 / 0.42', 'description': 'paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42', 'interventionNames': ['Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)']}], 'interventions': [{'name': 'HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)', 'type': 'DRUG', 'otherNames': ['Venofundin 6%, Tetraspan 6%'], 'description': 'solution for intravenous infusion applied according to SmPC', 'armGroupLabels': ['HES 130 / 0.42']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Donauspital SMZ-OST', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brno', 'country': 'Czechia', 'facility': "Clinic of Children's Anaesthesiology and Resuscitation", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Clinic of Anaesthesiology and Resuscitation', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Klinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Olgahospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'S. Orsola Hospital, University hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Mesich Centrum (AMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': "Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'R. Suempelmann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MHH Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Elke von Kleist', 'oldOrganization': 'B. Braun Melsungen AG'}}}}