Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-05 @ 2:53 AM
Study NCT ID:
NCT00618293
Status:
WITHDRAWN
Last Update Posted:
2012-01-05
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patient met the criteria for inclusion in the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds', 'timeFrame': 'begin of surgery and 48h after administration of medication'}], 'secondaryOutcomes': [{'measure': 'Assessment of adverse events and viral safety', 'timeFrame': '1.perioperative 2. during hospital admission 3. within 90 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraoperative bleeding', 'aortic-valve replacement', 'aortic stenosis', 'Von Willebrand', 'HEAMATE'], 'conditions': ['Blood Loss, Surgical']}, 'descriptionModule': {'briefSummary': 'Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement\n* Caucasian\n* written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)\n\nExclusion Criteria:\n\n* active endocarditis\n* history suggestive for inherited oe acquired bleeding disorder\n* concomitant coronary heart disease\n* agents impairing platelet function up to 14 days before surgery\n* Pregnancy\n* inherited platelet function\n* known intolerance against HAEMATE HS\n* previous thromboembolic complications\n* Hepatitis B, C or HIV infection\n* previous chemotherapy\n* emergency surgery within the last 7 days\n* weight \\< 50 kg and \\> 100 kg'}, 'identificationModule': {'nctId': 'NCT00618293', 'acronym': 'HAVAS', 'briefTitle': 'Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)', 'orgStudyIdInfo': {'id': 'BI8021_5101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'intravenous infusion of Haemate (dosage dependent on body weight)', 'interventionNames': ['Drug: Haemate HS']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'intravenous infusion of 0.9% NaCl solution', 'interventionNames': ['Other: NaCl-solution']}], 'interventions': [{'name': 'Haemate HS', 'type': 'DRUG', 'description': 'intravenous infusion of Haemate (dosage dependent on body weight)', 'armGroupLabels': ['1']}, {'name': 'NaCl-solution', 'type': 'OTHER', 'description': 'intravenous infusion of 0.9%NaCl-Solution', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Klinik für Kardiovaskuläre Chirurgie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Peter Feindt, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kardiovaskuläre Chirurgie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSL Behring', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Heinrich-Heine University, represented by Principal investigator Prof. Feindt', 'oldOrganization': 'Department of Hemostasis and Transfusion Medicine'}}}}