Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00328133
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2006-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012771', 'term': 'Shock, Hemorrhagic'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recombinant Factor VIIa', 'traumatic hemorrhage', 'hemorrhagic shock', 'coagulopathy'], 'conditions': ['Traumatic Hemorrhage', 'Hemorrhagic Shock']}, 'referencesModule': {'references': [{'pmid': '21115374', 'type': 'RESULT', 'citation': 'Knudson MM, Cohen MJ, Reidy R, Jaeger S, Bacchetti P, Jin C, Wade CE, Holcomb JB. Trauma, transfusions, and use of recombinant factor VIIa: A multicenter case registry report of 380 patients from the Western Trauma Association. J Am Coll Surg. 2011 Jan;212(1):87-95. doi: 10.1016/j.jamcollsurg.2010.08.020. Epub 2010 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:\n\n* The timing of administration\n* Selection of appropriate patients who are most likely to benefit\n* The effective dose in injured patients\n* The potential need for repeated dosing\n* The need for administration of platelets and correction of acidosis prior to administering the first dose\n* The risks associated with the use of rFVIIa including venous and/or arterial thrombosis\n* The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications\n* An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.', 'detailedDescription': "This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective and prospective observational case review study on traumatically injured adult patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCoagulopathy treated with rFVIIa\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT00328133', 'briefTitle': 'The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry', 'orgStudyIdInfo': {'id': 'H6693-27309-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco, San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Margaret Knudson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Western Trauma Association', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'American Association for the Surgery of Trauma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}