- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00670540
Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)
En prospektiv epidemiologisk multicenterkohortstudie på patienter som är kliniskt misstänkta för djup ventrombos eller lungemboli
Syftet med denna studie är att fastställa olika riskfaktorer för tromboembolisk sjukdom. Olika punkter kommer att studeras
- har olika typer av tromboembolisk sjukdom (distal djup ventrombos (DVT), proximal DVT, lungemboli (PE) och DVT, PE utan DVT) samma kliniska betydelse (riskfaktorer och prognos) ?
- Är det nödvändigt att få en detaljerad historia av tromboembolisk sjukdom?
- Har äldre patienter särskilda riskfaktorer?
- Modifierar förebyggande behandlingar nivån av riskfaktorer och de kliniska tecknen på tromboembolisk sjukdom?
- Har prediktiva kliniska resultat samma prestanda för både in- och polikliniska patienter?
- Kan patienter med en potentiell hög nivå av tromboembolisk risk (kirurgi, graviditet) men inga kliniska tromboemboliska symtom utveckla en låg risk?
- Sjukdomens utveckling hos patienter med negativa eller positiva explorativa tester för venös tromboembolism (VTE).
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Chenee, Belgien
- University Hospital ND des Bruyeres Liege
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Abbeville, Frankrike
- General Hospital
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Albertville, Frankrike, 73200
- Office-based Specialist in vascular medecine
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Albi, Frankrike, 81000
- Office-based Specialist in vascular medecine
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Alencon, Frankrike, 61000
- Office-based Specialist in vascular medecine
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Ales, Frankrike, 30100
- Office-based Specialist in vascular medecine
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Ambares, Frankrike, 33440
- Office-based Specialist in vascular medecine
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Amberieu En Buget, Frankrike, 01500
- Office-based Specialist in vascular medecine
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Amiens, Frankrike
- University Hospital
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Amiens, Frankrike, 80000
- Office-based Specialist in vascular medecine
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Ancenis, Frankrike, 44150
- Office-based Specialist in vascular medecine
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Angers, Frankrike
- University Hospital
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Angers, Frankrike, 49000
- Office-based Specialist in vascular medecine
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Annecy, Frankrike
- Hospital
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Annecy, Frankrike, 74000
- Office-based Specialist in vascular medecine
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Armentieres, Frankrike
- Hospital
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Arnouville-les-Gonesse, Frankrike, 95400
- Office-based Specialist in vascular medecine
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Arpajon, Frankrike, 91290
- Office-based Specialist in vascular medecine
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Arras, Frankrike, 62000
- Office-based Specialist in vascular medecine
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Aubenas, Frankrike, 07200
- Office-based Specialist in vascular medecine
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Auch, Frankrike
- Hospital
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Auxerre, Frankrike, 89000
- Office-based Specialist in vascular medecine
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Bagnoles-de-l'orme, Frankrike, 61140
- Office-based Specialist in vascular medecine
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Beauvais, Frankrike, 60000
- Office-based Specialist in vascular medecine
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Belfort, Frankrike
- University Hospital
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Bergerac, Frankrike, 24100
- Office-based Specialist in vascular medecine
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Besancon, Frankrike, 25000
- Office-based Specialist in vascular medecine
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Beziers, Frankrike, 35500
- Office-based Specialist in vascular medecine
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Blagnac, Frankrike, 31700
- Office-based Specialist in vascular medecine
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Bordeaux, Frankrike, 33000
- Office-based Specialist in vascular medecine
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Bordeaux, Frankrike
- Hospital St ANDRE
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Boulogne Sur Mer, Frankrike, 62200
- Office-based Specialist in vascular medecine
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Bourg En Bresse, Frankrike, 01000
- Office-based Specialist in vascular medecine
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Bourgoin Jallieu, Frankrike, 38300
- Office-based Specialist in vascular medecine
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Brest, Frankrike, 29200
- Office-based Specialist in vascular medecine
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Brest, Frankrike
- University Hospital La Cavale Blanche
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Bretenoux, Frankrike, 46130
- Office-based Specialist in vascular medecine
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Bretigny Sur Orge, Frankrike, 91220
- Office-based Specialist in vascular medecine
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Bron, Frankrike, 69500
- Office-based Specialist in vascular medecine
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Cabestany, Frankrike, 66330
- Office-based Specialist in vascular medecine
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Caen, Frankrike
- University Hospital
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Caluire Et Cuire, Frankrike, 69300
- Office-based Specialist in vascular medecine
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Cambrai, Frankrike, 59400
- Office-based Specialist in vascular medecine
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Cannes, Frankrike, 06400
- Office-based Specialist in vascular medecine
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Carcassonne, Frankrike, 11000
- Office-based Specialist in vascular medecine
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Carcassonne, Frankrike
- Hospital Antoine Gayraud
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Castanet Tolosan, Frankrike, 31320
- Office-based Specialist in vascular medecine
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Castres, Frankrike, 81100
- Office-based Specialist in vascular medecine
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Cenon, Frankrike, 33150
- Office-based Specialist in vascular medecine
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Chalon En Champagne, Frankrike, 51000
- Office-based Specialist in vascular medecine
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Chalon Sur Saone, Frankrike, 71100
- Office-based Specialist in vascular medecine
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Chambery, Frankrike
- Hospital
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Chambery, Frankrike, 73000
- Office-based Specialist in vascular medecine
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Champagnole, Frankrike, 39300
- Office-based Specialist in vascular medecine
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Chantilly, Frankrike, 60500
- Office-based Specialist in vascular medecine
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Charleville Mezieres, Frankrike, 08000
- Office-based Specialist in vascular medecine
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Chartres, Frankrike, 28000
- Office-based Specialist in vascular medecine
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Chateaubriant, Frankrike, 44110
- Office-based Specialist in vascular medecine
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Cholet, Frankrike, 49300
- Office-based Specialist in vascular medecine
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Clamart, Frankrike, 92140
- Office-based Specialist in vascular medecine
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Clapiers, Frankrike, 34830
- Office-based Specialist in vascular medecine
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Clermont Ferrand, Frankrike, 63000
- Office-based Specialist in vascular medecine
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Clermont Ferrand, Frankrike
- Hospital Hôtel Dieu
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Clermont L'Herault, Frankrike, 34800
- Office-based Specialist in vascular medecine
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Clisson, Frankrike, 44190
- Office-based Specialist in vascular medecine
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Cluses, Frankrike, 74300
- Office-based Specialist in vascular medecine
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Colomiers, Frankrike, 31770
- Office-based Specialist in vascular medecine
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Compiegne, Frankrike
- General Hospital
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Coulommiers, Frankrike, 77120
- Office-based Specialist in vascular medecine
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Crolles, Frankrike, 38920
- Office-based Specialist in vascular medecine
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Denain, Frankrike, 59220
- Office-based Specialist in vascular medecine
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Dieppe, Frankrike, 76200
- Office-based Specialist in vascular medecine
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Dijon, Frankrike
- University Hospital
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Dijon, Frankrike, 21000
- Office-based Specialist in vascular medecine
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Dijon, Frankrike
- Hospital Bocage
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Draguignan, Frankrike, 83300
- Office-based Specialist in vascular medecine
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Echirolles, Frankrike, 38130
- Office-based Specialist in vascular medecine
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Ermont, Frankrike, 95120
- Office-based Specialist in vascular medecine
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Evreux, Frankrike, 27000
- Office-based Specialist in vascular medecine
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Fecamp, Frankrike, 76400
- Office-based Specialist in vascular medecine
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Feytiat, Frankrike, 87220
- Office-based Specialist in vascular medecine
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Figeac, Frankrike, 46100
- Office-based Specialist in vascular medecine
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Flers, Frankrike
- Hospital
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Foix, Frankrike, 09000
- Office-based Specialist in vascular medecine
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Foix, Frankrike
- Hospital Val D'ariège
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Fontenay Le Comte, Frankrike, 85200
- Office-based Specialist in vascular medecine
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Glanes, Frankrike, 46130
- Office-based Specialist in vascular medecine
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Grenoble, Frankrike, 38043
- University Hospital Grenoble
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Grenoble, Frankrike, 38000
- Office-based Specialist in vascular medecine
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Gruchet Le Valasse, Frankrike, 76210
- Office-based Specialist in vascular medecine
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Hoenheim, Frankrike, 67800
- Office-based Specialist in vascular medecine
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Issy Les Moulineaux, Frankrike, 92130
- Office-based Specialist in vascular medecine
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Istres, Frankrike, 13800
- Office-based Specialist in vascular medecine
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L'ile Rousse, Frankrike, 20220
- Office-based Specialist in vascular medecine
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La Roche Sur Yon, Frankrike, 85000
- Office-based Specialist in vascular medecine
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La Roche Sur Yon, Frankrike
- Departemental Hospital
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La Rochelle, Frankrike, 17000
- Office-based Specialist in vascular medecine
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Lannion, Frankrike, 22300
- Office-based Specialist in vascular medecine
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Lattes, Frankrike, 34970
- Office-based Specialist in vascular medecine
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Laval, Frankrike, 53000
- Office-based Specialist in vascular medecine
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Laxou, Frankrike, 54520
- Office-based Specialist in vascular medecine
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Le Chesnay, Frankrike
- Hospital Versailles
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Le Mans, Frankrike, 72000
- Office-based Specialist in vascular medecine
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Le Quesnoy, Frankrike, 59530
- Office-based Specialist in vascular medecine
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Levallois, Frankrike, 92300
- Office-based Specialist in vascular medecine
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Limoges, Frankrike, 87000
- Office-based Specialist in vascular medecine
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Lisieux, Frankrike, 14100
- Office-based Specialist in vascular medecine
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Lomme, Frankrike
- Hospital Saint Philibert
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Longjumeau, Frankrike, 91160
- Office-based Specialist in vascular medecine
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Longwy, Frankrike, 54440
- Office-based Specialist in vascular medecine
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Lons Le Saunier, Frankrike, 39000
- Office-based Specialist in vascular medecine
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Lorient, Frankrike, 56100
- Office-based Specialist in vascular medecine
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Louviers, Frankrike, 27400
- Office-based Specialist in vascular medecine
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Lyon, Frankrike
- Hospital Edouard Herriot
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Lyon, Frankrike
- University Hospital
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Malemort Sur Correze, Frankrike, 19360
- Office-based Specialist in vascular medecine
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Manosque, Frankrike, 04100
- Office-based Specialist in vascular medecine
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Mantes La Jolie, Frankrike, 78200
- Office-based Specialist in vascular medecine
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Marcq En Baroeul, Frankrike, 59700
- Office-based Specialist in vascular medecine
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Marseille, Frankrike, 13000
- Office-based Specialist in vascular medecine
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Martinique, Frankrike, 97000
- Office-based Specialist in vascular medecine
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Maurepas, Frankrike, 78310
- Office-based Specialist in vascular medecine
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Meaux, Frankrike, 77100
- Office-based Specialist in vascular medecine
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Metz, Frankrike, 57000
- Office-based Specialist in vascular medecine
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Meudon, Frankrike, 92190
- Office-based Specialist in vascular medecine
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Moissac, Frankrike, 82200
- Office-based Specialist in vascular medecine
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Montaigu, Frankrike, 85600
- Office-based Specialist in vascular medecine
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Montbeliard, Frankrike, 25200
- Office-based Specialist in vascular medecine
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Montbeliard, Frankrike
- General Hospital
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Montivilliers, Frankrike
- Hospital Jacques Monod
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Montlucon, Frankrike, 03100
- Office-based Specialist in vascular medecine
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Montlucon, Frankrike
- Hospital
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Montmorillon, Frankrike
- Hospital
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Montpellier, Frankrike, 34000
- Office-based Specialist in vascular medecine
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Montpellier, Frankrike
- Hospital St Eloi
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Mulhouse, Frankrike, 68100
- Office-based Specialist in vascular medecine
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NOUMEA (Nouvelle Calédonie), Frankrike, 98800
- Office-based Specialist in vascular medecine
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Nancy, Frankrike, 54000
- Office-based Specialist in vascular medecine
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Nantes, Frankrike, 44000
- Office-based Specialist in vascular medecine
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Narbonne, Frankrike, 11100
- Office-based Specialist in vascular medecine
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Nice, Frankrike, 06000
- Office-based Specialist in vascular medecine
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Nimes, Frankrike, 30000
- Office-based Specialist in vascular medecine
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Niort, Frankrike, 79000
- Office-based Specialist in vascular medecine
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Noyal Pontivy, Frankrike, 56920
- Office-based Specialist in vascular medecine
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Noyon, Frankrike, 60400
- Office-based Specialist in vascular medecine
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Orange, Frankrike, 84100
- Office-based Specialist in vascular medecine
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Orleans, Frankrike, 45000
- Office-based Specialist in vascular medecine
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Orleans La Source, Frankrike
- Regional Hospital
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Paris, Frankrike, 75000
- Office-based Specialist in vascular medecine
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Paris, Frankrike
- Hospital Croix Saint Simon
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Perigueux, Frankrike
- Hospital
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Peronne, Frankrike, 80200
- Office-based Specialist in vascular medecine
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Pessac, Frankrike, 33600
- Office-based Specialist in vascular medecine
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Poissy, Frankrike, 78300
- Office-based Specialist in vascular medecine
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Poitiers, Frankrike, 86000
- Office-based Specialist in vascular medecine
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Pontarlier, Frankrike, 25300
- Office-based Specialist in vascular medecine
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Pornic, Frankrike, 44210
- Office-based Specialist in vascular medecine
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Puilboreau, Frankrike, 17000
- Office-based Specialist in vascular medecine
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Quimper, Frankrike, 29000
- Office-based Specialist in vascular medecine
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Rambouillet, Frankrike, 78120
- Office-based Specialist in vascular medecine
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Redon, Frankrike, 35600
- Office-based Specialist in vascular medecine
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Reims, Frankrike, 51200
- Office-based Specialist in vascular medecine
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Reims, Frankrike
- University Hospital
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Riom, Frankrike, 63200
- Office-based Specialist in vascular medecine
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Rivesaltes, Frankrike, 66600
- Office-based Specialist in vascular medecine
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Rochefort, Frankrike, 17300
- Office-based Specialist in vascular medecine
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Rodez, Frankrike, 12000
- Office-based Specialist in vascular medecine
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Rodez, Frankrike, MD
- Hospital
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Romans Sur Isere, Frankrike, 26000
- Office-based Specialist in vascular medecine
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Rouen, Frankrike, 76000
- Office-based Specialist in vascular medecine
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Sable Sur Sarthe, Frankrike, 72300
- Office-based Specialist in vascular medecine
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Saint Aubin de Medoc, Frankrike, 33160
- Office-based Specialist in vascular medecine
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Saint Benoit, Frankrike, 86200
- Office-based Specialist in vascular medecine
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Saint Brieuc, Frankrike, 22000
- Office-based Specialist in vascular medecine
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Saint Chamond, Frankrike, 42400
- Office-based Specialist in vascular medecine
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Saint Cloud, Frankrike, 92210
- Office-based Specialist in vascular medecine
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Saint Cyr L'ecole, Frankrike, 78210
- Office-based Specialist in vascular medecine
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Saint Egreve, Frankrike, 38120
- Office-based Specialist in vascular medecine
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Saint Etienne, Frankrike, 42000
- Office-based Specialist in vascular medecine
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Saint Etienne, Frankrike
- University Hospital
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Saint Gaudens, Frankrike, 31800
- Office-based Specialist in vascular medecine
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Saint Genevieve Des Bois, Frankrike, 91700
- Office-based Specialist in vascular medecine
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Saint Germain En Laye, Frankrike, 78100
- Office-based Specialist in vascular medecine
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Saint Hilaire Du Touvert, Frankrike
- Cmc Les Petites Roches
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Saint Lo, Frankrike, 50000
- Office-based Specialist in vascular medecine
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Saint Lo, Frankrike
- Memorial Hospital
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Saint Martin Boulogne, Frankrike, 62280
- Office-based Specialist in vascular medecine
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Saint Pierre (ile de La Reunion), Frankrike, 97410
- Office-based Specialist in vascular medecine
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Saint Priest, Frankrike, 69800
- Office-based Specialist in vascular medecine
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Saint Quentin, Frankrike
- Hospital
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Sallanches, Frankrike, 74700
- Office-based Specialist in vascular medecine
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Salon de Provence, Frankrike, 13300
- Office-based Specialist in vascular medecine
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Sarcelles, Frankrike, 95200
- Office-based Specialist in vascular medecine
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Sarrebourg, Frankrike, 57400
- Office-based Specialist in vascular medecine
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Sarreguemines, Frankrike, 57200
- Office-based Specialist in vascular medecine
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Saverne, Frankrike, 67700
- Office-based Specialist in vascular medecine
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Savigny Sur Orge, Frankrike, 91600
- Office-based Specialist in vascular medecine
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Sceaux, Frankrike, 92330
- Office-based Specialist in vascular medecine
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Selestat, Frankrike, 67600
- Office-based Specialist in vascular medecine
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Sevres, Frankrike, 92310
- Office-based Specialist in vascular medecine
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Strasbourg, Frankrike, 67000
- Office-based Specialist in vascular medecine
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Strasbourg, Frankrike
- Regional University Hospital
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Talant, Frankrike, 21000
- Office-based Specialist in vascular medecine
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Tarare, Frankrike, 69170
- Office-based Specialist in vascular medecine
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Toulouse, Frankrike
- University Hospital
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Toulouse, Frankrike, 31000
- Office-based Specialist in vascular medecine
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Toulouse, Frankrike
- University Hospital Rangueil Larrey
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Toulouse, Frankrike
- University Hospital Rangueil
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Tours, Frankrike, 37000
- Office-based Specialist in vascular medecine
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Trois Rivieres (guadeloupe), Frankrike, 97114
- Office-based Specialist in vascular medecine
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Troyes, Frankrike, 10000
- Office-based Specialist in vascular medecine
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Valence, Frankrike, 26000
- Office-based Specialist in vascular medecine
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Vannes, Frankrike, 56000
- Office-based Specialist in vascular medecine
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Vendome, Frankrike, 41100
- Office-based Specialist in vascular medecine
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Venissieux, Frankrike, 69200
- Office-based Specialist in vascular medecine
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Verrieres Le Buisson, Frankrike, 91370
- Office-based Specialist in vascular medecine
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Versailles, Frankrike, 78000
- Office-based Specialist in vascular medecine
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Vesoul, Frankrike, 70000
- Office-based Specialist in vascular medecine
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Vichy, Frankrike, 03200
- Office-based Specialist in vascular medecine
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Vienne, Frankrike, 38200
- Office-based Specialist in vascular medecine
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Villebon Sur Yvette, Frankrike, 91140
- Office-based Specialist in vascular medecine
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Villefranche Sur Saone, Frankrike, 69400
- Office-based Specialist in vascular medecine
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Villemoisson Sur Orge, Frankrike, 91360
- Office-based Specialist in vascular medecine
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Villeurbanne, Frankrike, 69100
- Office-based Specialist in vascular medecine
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Vincennes, Frankrike, 94300
- Office-based Specialist in vascular medecine
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Viroflay, Frankrike, 78220
- Office-based Specialist in vascular medecine
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Vizille, Frankrike, 38220
- Office-based Specialist in vascular medecine
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Voiron, Frankrike, 38500
- Office-based Specialist in vascular medecine
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Wissembourg, Frankrike, 67160
- Office-based Specialist in vascular medecine
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Wizernes, Frankrike, 62570
- Office-based Specialist in vascular medecine
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Basse Terre, Guadeloupe, 97100
- Office-based Specialist in vascular medecine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Alla manliga eller kvinnliga slutenvårdar och öppenvårdspatienter sjukhus och kontorsbaserade. 18 år med klinisk misstanke om djup ventrombos (DVT) eller lungemboli (PE).
Patienter med kognitiva störningar eller språkstörningar som förhindrade insamling av riskfaktordata genom anamnes exkluderades.
Beskrivning
Inklusionskriterier:
- patient över 18 år
- man eller kvinna
- patienter med kliniska tromboemboliska tecken (djup ventrombos eller lungemboli)
Exklusions kriterier:
- patient under 18 år
- patienten inte kan förstå
- patient som vägrade att delta
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
1
patienter med misstänkt djup ventrombos (DVT) eller lungemboli (PE)
|
patienter med en klinisk misstanke om venös tromboembolism (VTE = djup ventrombos eller lungemboli) var berättigade
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel deltagare som utvecklade en ny eller återkommande venös tromboembolism (VTE)
Tidsram: vid 3 år
|
ny VTE som kan uppstå under uppföljning för inga VTE-patienter vid inkluderingen.
Eller VTE-recidiv för VTE-patienter vid inklusionen.
|
vid 3 år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Andel deltagare som utvecklade stora blödningshändelser
Tidsram: vid 3 år
|
vid 3 år
|
|
Procentandel av deltagare med behandling Antikoagulantia ordinerats
Tidsram: efter inkludering
|
efter inkludering
|
|
Andel deltagare som utvecklade kardiovaskulära händelser
Tidsram: vid 3 år
|
vid 3 år
|
|
Andel deltagare som dog av någon orsak
Tidsram: vid 3 år
|
vid 3 år
|
|
Andel deltagare som utvecklade cancer
Tidsram: vid 3 år
|
vid 3 år
|
|
Andel deltagare som utvecklade venös insufficiens (bensår)
Tidsram: vid 3 år
|
vid 3 år
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jean Luc JB BOSSON, MD, University Hospital, Grenoble
- Studiestol: Marie Antoinette SEVESTRE, MD, Amiens University Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quere I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. doi: 10.1016/s0398-0499(05)88206-x. French.
- Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
- Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.
- Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20. doi: 10.1001/archinte.160.22.3415.
- Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9. doi: 10.1001/archinte.163.10.1213.
- Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quere I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.
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