Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-01 @ 10:08 PM
Study NCT ID:
NCT00163592
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2004-02'}, 'lastUpdateSubmitDate': '2006-10-20', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Vascular reconstruction', 'Polytetraflouroethylene (PTFE) prosthesis'], 'conditions': ['Femoral Vascular Anastomosis']}, 'descriptionModule': {'briefSummary': 'This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis'}, 'identificationModule': {'nctId': 'NCT00163592', 'briefTitle': 'Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis', 'orgStudyIdInfo': {'id': '530301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tissucol®', 'type': 'DRUG'}, {'name': 'Control: Conventional treatment, i.e. compression with swabs', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'General Hospital (AKH) Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Landeskrankenhaus Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '71229', 'city': 'Leonberg', 'country': 'Germany', 'facility': 'Leonberg Hospital, Department of Vascular Surgery', 'geoPoint': {'lat': 48.8, 'lon': 9.01667}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'University Clinics of Magdeburg, Department of Vascular Surgery', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '90340', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Süd, Department of Vascular Surgery', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Thomas Bürger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinics of Magdeburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}}}}