Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-04-08 @ 3:34 AM
Study NCT ID:
NCT00546169
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005340', 'term': 'Fibrinogen'}, {'id': 'D013917', 'term': 'Thrombin'}, {'id': 'C518955', 'term': 'TachoSil'}], 'ancestors': [{'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2007-10-17', 'studyFirstSubmitQcDate': '2007-10-17', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Patients undergoing elective or acute cholecystectomy'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': "* Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)\n* Evaluation of TachoSil in laparoscopic cholecystectomy\n* Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy\n* Pharmaco-economic evaluation\n* Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.\n\nAim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective or acute cholecystectomy\n* The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)'}, 'identificationModule': {'nctId': 'NCT00546169', 'briefTitle': 'Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)', 'orgStudyIdInfo': {'id': 'TC-027-DE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: Fibrinogen (human) + thrombin (human) (TachoSil)']}], 'interventions': [{'name': 'Fibrinogen (human) + thrombin (human) (TachoSil)', 'type': 'DRUG', 'description': 'haemorrhages in cholecystectomy', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Nycomed', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Nycomed Clinical Trial Operations', 'role': 'STUDY_CHAIR', 'affiliation': 'Headquaters'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nycomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nycomed', 'oldOrganization': 'Clinical Trial Operations'}}}}