Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT01532661
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2011-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'use of rFVIIa in haemorrhagic trauma compared to guidelines', 'timeFrame': 'twenty four hours', 'description': 'Deviations with European guidelines use of rFVIIa'}], 'secondaryOutcomes': [{'measure': 'medico economic evaluation', 'timeFrame': 'one year', 'description': 'number of patients receiving rFVIIa by year and posology by patient'}, {'measure': 'security and efficiency use of rFVVa', 'timeFrame': 'thirty days', 'description': 'Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TRAUMA', 'HAEMORRHAGIC', 'rVIIa', 'Complication of Trauma hemorrhage', 'bleeding', 'rFVIIa administration for hemorrhage after trauma'], 'conditions': ['Hemorrhage', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '16096533', 'type': 'BACKGROUND', 'citation': 'Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8. doi: 10.1097/01.ta.0000171453.37949.b7.'}, {'pmid': '11535886', 'type': 'RESULT', 'citation': 'Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001 Sep;51(3):431-8; discussion 438-9. doi: 10.1097/00005373-200109000-00002.'}, {'pmid': '17184516', 'type': 'RESULT', 'citation': 'Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care. 2006;10(6):R178. doi: 10.1186/cc5133.'}, {'pmid': '16096555', 'type': 'RESULT', 'citation': 'Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005 Jul;59(1):150-4. doi: 10.1097/01.ta.0000171470.39742.8e.'}, {'pmid': '17629661', 'type': 'RESULT', 'citation': 'Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Negrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. doi: 10.1016/j.annfar.2007.06.001. Epub 2007 Jul 16. French.'}]}, 'descriptionModule': {'briefSummary': 'The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa.\n\nThose patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization.\n\nThe aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.', 'detailedDescription': 'It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome.\n\nISS and TRISS score were calculated to predict mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted in ICU after massive bleeding trauma and received rFVIIa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people affiliated to social security\n* patients admitted in ISU for haemorrhagic trauma\n* patients received rFVIIa after the other treatment for bleeding control\n\nExclusion Criteria:\n\n* allergy or hypersensitivity to rVIIa or one of its component'}, 'identificationModule': {'nctId': 'NCT01532661', 'acronym': 'NOVO7', 'briefTitle': 'National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology', 'orgStudyIdInfo': {'id': 'DCIC 07 20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observational study', 'description': 'haemorrhagic trauma received rFVIIa', 'interventionNames': ['Other: observational study']}], 'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'data collected by investigators', 'armGroupLabels': ['observational study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alençon', 'country': 'France', 'facility': 'MEROUANI', 'geoPoint': {'lat': 48.43476, 'lon': 0.09311}}, {'city': 'Amiens', 'country': 'France', 'facility': 'LAIGLE', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Annecy', 'country': 'France', 'facility': 'SANTRE', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'MOREL', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'SEDILLOT', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Caen', 'country': 'France', 'facility': 'BULEON', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'MIQUET', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Clamart', 'country': 'France', 'facility': 'DEBIEN', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'GUELON', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clichy', 'country': 'France', 'facility': 'PEASE', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Créteil', 'country': 'France', 'facility': 'COOK', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'country': 'France', 'facility': 'NADJI', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Gap', 'country': 'France', 'facility': 'Vinsiniti', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'DECLETY', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Duranteau', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'GARRIGUE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'FLOCARD', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'GARCIN', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Metz', 'country': 'France', 'facility': 'FAVIER', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHARBIT', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'YUNG', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'AUDIBERT', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHUPIN', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'ICHAI', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'LEFRANT', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'country': 'France', 'facility': 'JOURNOIS', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'LANGERON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Mateo A Loris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'DAVID', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'Nanadoumgar', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'country': 'France', 'facility': 'LEPOUSE', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Bleichner', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'GUITARD', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'MARTIN', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'FREYS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulon', 'country': 'France', 'facility': 'MEAUDRE', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'OLIVIER', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Vannes', 'country': 'France', 'facility': 'LEBAS', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'JAULT', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'PAYEN JF, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}