- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00670540
Épidémiologie de la maladie thromboembolique : une étude de cohorte (OPTIMEV)
Une étude épidémiologique prospective de cohorte multicentrique sur des patients cliniquement suspectés de thrombose veineuse profonde ou d'embolie pulmonaire
Le but de cette étude est de déterminer les différents facteurs de risque de la maladie thromboembolique. Différents points seront étudiés
- les différents types de maladies thromboemboliques (thrombose veineuse profonde distale (TVP), TVP proximale, embolie pulmonaire (EP) et TVP, EP sans TVP) ont-ils la même signification clinique (facteurs de risque et pronostic) ?
- Est-il nécessaire d'obtenir un historique détaillé de la maladie thromboembolique ?
- Les patients âgés présentent-ils des facteurs de risque particuliers ?
- Les traitements préventifs modifient-ils le niveau des facteurs de risque et les signes cliniques de la maladie thromboembolique ?
- Les scores cliniques prédictifs ont-ils les mêmes performances en hospitalisation et en ambulatoire ?
- Les patients présentant un risque thromboembolique potentiellement élevé (chirurgie, grossesse) mais sans symptômes cliniques thromboemboliques peuvent-ils développer un risque faible ?
- L'évolution de la maladie chez les patients avec des tests exploratoires de thromboembolie veineuse (TEV) négatifs ou positifs.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Chenee, Belgique
- University Hospital ND des Bruyeres Liege
-
-
-
-
-
Abbeville, France
- General Hospital
-
Albertville, France, 73200
- Office-based Specialist in vascular medecine
-
Albi, France, 81000
- Office-based Specialist in vascular medecine
-
Alencon, France, 61000
- Office-based Specialist in vascular medecine
-
Ales, France, 30100
- Office-based Specialist in vascular medecine
-
Ambares, France, 33440
- Office-based Specialist in vascular medecine
-
Amberieu En Buget, France, 01500
- Office-based Specialist in vascular medecine
-
Amiens, France
- University Hospital
-
Amiens, France, 80000
- Office-based Specialist in vascular medecine
-
Ancenis, France, 44150
- Office-based Specialist in vascular medecine
-
Angers, France
- University Hospital
-
Angers, France, 49000
- Office-based Specialist in vascular medecine
-
Annecy, France
- Hospital
-
Annecy, France, 74000
- Office-based Specialist in vascular medecine
-
Armentieres, France
- Hospital
-
Arnouville-les-Gonesse, France, 95400
- Office-based Specialist in vascular medecine
-
Arpajon, France, 91290
- Office-based Specialist in vascular medecine
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Arras, France, 62000
- Office-based Specialist in vascular medecine
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Aubenas, France, 07200
- Office-based Specialist in vascular medecine
-
Auch, France
- Hospital
-
Auxerre, France, 89000
- Office-based Specialist in vascular medecine
-
Bagnoles-de-l'orme, France, 61140
- Office-based Specialist in vascular medecine
-
Beauvais, France, 60000
- Office-based Specialist in vascular medecine
-
Belfort, France
- University Hospital
-
Bergerac, France, 24100
- Office-based Specialist in vascular medecine
-
Besancon, France, 25000
- Office-based Specialist in vascular medecine
-
Beziers, France, 35500
- Office-based Specialist in vascular medecine
-
Blagnac, France, 31700
- Office-based Specialist in vascular medecine
-
Bordeaux, France, 33000
- Office-based Specialist in vascular medecine
-
Bordeaux, France
- Hospital St ANDRE
-
Boulogne Sur Mer, France, 62200
- Office-based Specialist in vascular medecine
-
Bourg En Bresse, France, 01000
- Office-based Specialist in vascular medecine
-
Bourgoin Jallieu, France, 38300
- Office-based Specialist in vascular medecine
-
Brest, France, 29200
- Office-based Specialist in vascular medecine
-
Brest, France
- University Hospital La Cavale Blanche
-
Bretenoux, France, 46130
- Office-based Specialist in vascular medecine
-
Bretigny Sur Orge, France, 91220
- Office-based Specialist in vascular medecine
-
Bron, France, 69500
- Office-based Specialist in vascular medecine
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Cabestany, France, 66330
- Office-based Specialist in vascular medecine
-
Caen, France
- University Hospital
-
Caluire Et Cuire, France, 69300
- Office-based Specialist in vascular medecine
-
Cambrai, France, 59400
- Office-based Specialist in vascular medecine
-
Cannes, France, 06400
- Office-based Specialist in vascular medecine
-
Carcassonne, France, 11000
- Office-based Specialist in vascular medecine
-
Carcassonne, France
- Hospital Antoine Gayraud
-
Castanet Tolosan, France, 31320
- Office-based Specialist in vascular medecine
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Castres, France, 81100
- Office-based Specialist in vascular medecine
-
Cenon, France, 33150
- Office-based Specialist in vascular medecine
-
Chalon En Champagne, France, 51000
- Office-based Specialist in vascular medecine
-
Chalon Sur Saone, France, 71100
- Office-based Specialist in vascular medecine
-
Chambery, France
- Hospital
-
Chambery, France, 73000
- Office-based Specialist in vascular medecine
-
Champagnole, France, 39300
- Office-based Specialist in vascular medecine
-
Chantilly, France, 60500
- Office-based Specialist in vascular medecine
-
Charleville Mezieres, France, 08000
- Office-based Specialist in vascular medecine
-
Chartres, France, 28000
- Office-based Specialist in vascular medecine
-
Chateaubriant, France, 44110
- Office-based Specialist in vascular medecine
-
Cholet, France, 49300
- Office-based Specialist in vascular medecine
-
Clamart, France, 92140
- Office-based Specialist in vascular medecine
-
Clapiers, France, 34830
- Office-based Specialist in vascular medecine
-
Clermont Ferrand, France, 63000
- Office-based Specialist in vascular medecine
-
Clermont Ferrand, France
- Hospital Hôtel Dieu
-
Clermont L'Herault, France, 34800
- Office-based Specialist in vascular medecine
-
Clisson, France, 44190
- Office-based Specialist in vascular medecine
-
Cluses, France, 74300
- Office-based Specialist in vascular medecine
-
Colomiers, France, 31770
- Office-based Specialist in vascular medecine
-
Compiegne, France
- General Hospital
-
Coulommiers, France, 77120
- Office-based Specialist in vascular medecine
-
Crolles, France, 38920
- Office-based Specialist in vascular medecine
-
Denain, France, 59220
- Office-based Specialist in vascular medecine
-
Dieppe, France, 76200
- Office-based Specialist in vascular medecine
-
Dijon, France
- University Hospital
-
Dijon, France, 21000
- Office-based Specialist in vascular medecine
-
Dijon, France
- Hospital Bocage
-
Draguignan, France, 83300
- Office-based Specialist in vascular medecine
-
Echirolles, France, 38130
- Office-based Specialist in vascular medecine
-
Ermont, France, 95120
- Office-based Specialist in vascular medecine
-
Evreux, France, 27000
- Office-based Specialist in vascular medecine
-
Fecamp, France, 76400
- Office-based Specialist in vascular medecine
-
Feytiat, France, 87220
- Office-based Specialist in vascular medecine
-
Figeac, France, 46100
- Office-based Specialist in vascular medecine
-
Flers, France
- Hospital
-
Foix, France, 09000
- Office-based Specialist in vascular medecine
-
Foix, France
- Hospital Val D'ariège
-
Fontenay Le Comte, France, 85200
- Office-based Specialist in vascular medecine
-
Glanes, France, 46130
- Office-based Specialist in vascular medecine
-
Grenoble, France, 38043
- University Hospital Grenoble
-
Grenoble, France, 38000
- Office-based Specialist in vascular medecine
-
Gruchet Le Valasse, France, 76210
- Office-based Specialist in vascular medecine
-
Hoenheim, France, 67800
- Office-based Specialist in vascular medecine
-
Issy Les Moulineaux, France, 92130
- Office-based Specialist in vascular medecine
-
Istres, France, 13800
- Office-based Specialist in vascular medecine
-
L'ile Rousse, France, 20220
- Office-based Specialist in vascular medecine
-
La Roche Sur Yon, France, 85000
- Office-based Specialist in vascular medecine
-
La Roche Sur Yon, France
- Departemental Hospital
-
La Rochelle, France, 17000
- Office-based Specialist in vascular medecine
-
Lannion, France, 22300
- Office-based Specialist in vascular medecine
-
Lattes, France, 34970
- Office-based Specialist in vascular medecine
-
Laval, France, 53000
- Office-based Specialist in vascular medecine
-
Laxou, France, 54520
- Office-based Specialist in vascular medecine
-
Le Chesnay, France
- Hospital Versailles
-
Le Mans, France, 72000
- Office-based Specialist in vascular medecine
-
Le Quesnoy, France, 59530
- Office-based Specialist in vascular medecine
-
Levallois, France, 92300
- Office-based Specialist in vascular medecine
-
Limoges, France, 87000
- Office-based Specialist in vascular medecine
-
Lisieux, France, 14100
- Office-based Specialist in vascular medecine
-
Lomme, France
- Hospital Saint Philibert
-
Longjumeau, France, 91160
- Office-based Specialist in vascular medecine
-
Longwy, France, 54440
- Office-based Specialist in vascular medecine
-
Lons Le Saunier, France, 39000
- Office-based Specialist in vascular medecine
-
Lorient, France, 56100
- Office-based Specialist in vascular medecine
-
Louviers, France, 27400
- Office-based Specialist in vascular medecine
-
Lyon, France
- Hospital Edouard Herriot
-
Lyon, France
- University Hospital
-
Malemort Sur Correze, France, 19360
- Office-based Specialist in vascular medecine
-
Manosque, France, 04100
- Office-based Specialist in vascular medecine
-
Mantes La Jolie, France, 78200
- Office-based Specialist in vascular medecine
-
Marcq En Baroeul, France, 59700
- Office-based Specialist in vascular medecine
-
Marseille, France, 13000
- Office-based Specialist in vascular medecine
-
Martinique, France, 97000
- Office-based Specialist in vascular medecine
-
Maurepas, France, 78310
- Office-based Specialist in vascular medecine
-
Meaux, France, 77100
- Office-based Specialist in vascular medecine
-
Metz, France, 57000
- Office-based Specialist in vascular medecine
-
Meudon, France, 92190
- Office-based Specialist in vascular medecine
-
Moissac, France, 82200
- Office-based Specialist in vascular medecine
-
Montaigu, France, 85600
- Office-based Specialist in vascular medecine
-
Montbeliard, France, 25200
- Office-based Specialist in vascular medecine
-
Montbeliard, France
- General Hospital
-
Montivilliers, France
- Hospital Jacques Monod
-
Montlucon, France, 03100
- Office-based Specialist in vascular medecine
-
Montlucon, France
- Hospital
-
Montmorillon, France
- Hospital
-
Montpellier, France, 34000
- Office-based Specialist in vascular medecine
-
Montpellier, France
- Hospital St Eloi
-
Mulhouse, France, 68100
- Office-based Specialist in vascular medecine
-
NOUMEA (Nouvelle Calédonie), France, 98800
- Office-based Specialist in vascular medecine
-
Nancy, France, 54000
- Office-based Specialist in vascular medecine
-
Nantes, France, 44000
- Office-based Specialist in vascular medecine
-
Narbonne, France, 11100
- Office-based Specialist in vascular medecine
-
Nice, France, 06000
- Office-based Specialist in vascular medecine
-
Nimes, France, 30000
- Office-based Specialist in vascular medecine
-
Niort, France, 79000
- Office-based Specialist in vascular medecine
-
Noyal Pontivy, France, 56920
- Office-based Specialist in vascular medecine
-
Noyon, France, 60400
- Office-based Specialist in vascular medecine
-
Orange, France, 84100
- Office-based Specialist in vascular medecine
-
Orleans, France, 45000
- Office-based Specialist in vascular medecine
-
Orleans La Source, France
- Regional Hospital
-
Paris, France, 75000
- Office-based Specialist in vascular medecine
-
Paris, France
- Hospital Croix Saint Simon
-
Perigueux, France
- Hospital
-
Peronne, France, 80200
- Office-based Specialist in vascular medecine
-
Pessac, France, 33600
- Office-based Specialist in vascular medecine
-
Poissy, France, 78300
- Office-based Specialist in vascular medecine
-
Poitiers, France, 86000
- Office-based Specialist in vascular medecine
-
Pontarlier, France, 25300
- Office-based Specialist in vascular medecine
-
Pornic, France, 44210
- Office-based Specialist in vascular medecine
-
Puilboreau, France, 17000
- Office-based Specialist in vascular medecine
-
Quimper, France, 29000
- Office-based Specialist in vascular medecine
-
Rambouillet, France, 78120
- Office-based Specialist in vascular medecine
-
Redon, France, 35600
- Office-based Specialist in vascular medecine
-
Reims, France, 51200
- Office-based Specialist in vascular medecine
-
Reims, France
- University Hospital
-
Riom, France, 63200
- Office-based Specialist in vascular medecine
-
Rivesaltes, France, 66600
- Office-based Specialist in vascular medecine
-
Rochefort, France, 17300
- Office-based Specialist in vascular medecine
-
Rodez, France, 12000
- Office-based Specialist in vascular medecine
-
Rodez, France, MD
- Hospital
-
Romans Sur Isere, France, 26000
- Office-based Specialist in vascular medecine
-
Rouen, France, 76000
- Office-based Specialist in vascular medecine
-
Sable Sur Sarthe, France, 72300
- Office-based Specialist in vascular medecine
-
Saint Aubin de Medoc, France, 33160
- Office-based Specialist in vascular medecine
-
Saint Benoit, France, 86200
- Office-based Specialist in vascular medecine
-
Saint Brieuc, France, 22000
- Office-based Specialist in vascular medecine
-
Saint Chamond, France, 42400
- Office-based Specialist in vascular medecine
-
Saint Cloud, France, 92210
- Office-based Specialist in vascular medecine
-
Saint Cyr L'ecole, France, 78210
- Office-based Specialist in vascular medecine
-
Saint Egreve, France, 38120
- Office-based Specialist in vascular medecine
-
Saint Etienne, France, 42000
- Office-based Specialist in vascular medecine
-
Saint Etienne, France
- University Hospital
-
Saint Gaudens, France, 31800
- Office-based Specialist in vascular medecine
-
Saint Genevieve Des Bois, France, 91700
- Office-based Specialist in vascular medecine
-
Saint Germain En Laye, France, 78100
- Office-based Specialist in vascular medecine
-
Saint Hilaire Du Touvert, France
- Cmc Les Petites Roches
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Saint Lo, France, 50000
- Office-based Specialist in vascular medecine
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Saint Lo, France
- Memorial Hospital
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Saint Martin Boulogne, France, 62280
- Office-based Specialist in vascular medecine
-
Saint Pierre (ile de La Reunion), France, 97410
- Office-based Specialist in vascular medecine
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Saint Priest, France, 69800
- Office-based Specialist in vascular medecine
-
Saint Quentin, France
- Hospital
-
Sallanches, France, 74700
- Office-based Specialist in vascular medecine
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Salon de Provence, France, 13300
- Office-based Specialist in vascular medecine
-
Sarcelles, France, 95200
- Office-based Specialist in vascular medecine
-
Sarrebourg, France, 57400
- Office-based Specialist in vascular medecine
-
Sarreguemines, France, 57200
- Office-based Specialist in vascular medecine
-
Saverne, France, 67700
- Office-based Specialist in vascular medecine
-
Savigny Sur Orge, France, 91600
- Office-based Specialist in vascular medecine
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Sceaux, France, 92330
- Office-based Specialist in vascular medecine
-
Selestat, France, 67600
- Office-based Specialist in vascular medecine
-
Sevres, France, 92310
- Office-based Specialist in vascular medecine
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Strasbourg, France, 67000
- Office-based Specialist in vascular medecine
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Strasbourg, France
- Regional University Hospital
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Talant, France, 21000
- Office-based Specialist in vascular medecine
-
Tarare, France, 69170
- Office-based Specialist in vascular medecine
-
Toulouse, France
- University Hospital
-
Toulouse, France, 31000
- Office-based Specialist in vascular medecine
-
Toulouse, France
- University Hospital Rangueil Larrey
-
Toulouse, France
- University Hospital Rangueil
-
Tours, France, 37000
- Office-based Specialist in vascular medecine
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Trois Rivieres (guadeloupe), France, 97114
- Office-based Specialist in vascular medecine
-
Troyes, France, 10000
- Office-based Specialist in vascular medecine
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Valence, France, 26000
- Office-based Specialist in vascular medecine
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Vannes, France, 56000
- Office-based Specialist in vascular medecine
-
Vendome, France, 41100
- Office-based Specialist in vascular medecine
-
Venissieux, France, 69200
- Office-based Specialist in vascular medecine
-
Verrieres Le Buisson, France, 91370
- Office-based Specialist in vascular medecine
-
Versailles, France, 78000
- Office-based Specialist in vascular medecine
-
Vesoul, France, 70000
- Office-based Specialist in vascular medecine
-
Vichy, France, 03200
- Office-based Specialist in vascular medecine
-
Vienne, France, 38200
- Office-based Specialist in vascular medecine
-
Villebon Sur Yvette, France, 91140
- Office-based Specialist in vascular medecine
-
Villefranche Sur Saone, France, 69400
- Office-based Specialist in vascular medecine
-
Villemoisson Sur Orge, France, 91360
- Office-based Specialist in vascular medecine
-
Villeurbanne, France, 69100
- Office-based Specialist in vascular medecine
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Vincennes, France, 94300
- Office-based Specialist in vascular medecine
-
Viroflay, France, 78220
- Office-based Specialist in vascular medecine
-
Vizille, France, 38220
- Office-based Specialist in vascular medecine
-
Voiron, France, 38500
- Office-based Specialist in vascular medecine
-
Wissembourg, France, 67160
- Office-based Specialist in vascular medecine
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Wizernes, France, 62570
- Office-based Specialist in vascular medecine
-
-
-
-
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Basse Terre, Guadeloupe, 97100
- Office-based Specialist in vascular medecine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Tous les patients hospitalisés et externes, hommes ou femmes, hospitalisés et en cabinet. 18 ans avec suspicion clinique de thrombose veineuse profonde (TVP) ou d'embolie pulmonaire (EP).
Les patients présentant des troubles cognitifs ou des troubles du langage empêchant la collecte de données sur les facteurs de risque par anamnèse ont été exclus.
La description
Critère d'intégration:
- patient de plus de 18 ans
- masculin ou féminin
- patients présentant des signes cliniques thromboemboliques (thrombose veineuse profonde ou embolie pulmonaire)
Critère d'exclusion:
- malade de moins de 18 ans
- patient incapable de comprendre
- patient qui a refusé de participer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
1
patients suspectés de thrombose veineuse profonde (TVP) ou d'embolie pulmonaire (EP)
|
les patients présentant une suspicion clinique de thromboembolie veineuse (TEV = thrombose veineuse profonde ou embolie pulmonaire) étaient éligibles
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pourcentage de participants qui ont développé une nouvelle ou une récidive de thromboembolie veineuse (TEV)
Délai: à 3 ans
|
nouveau TEV pouvant survenir au cours du suivi pour aucun patient TEV à l'inclusion.
Ou récidive de TEV pour les patients TEV à l'inclusion.
|
à 3 ans
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Pourcentage de participants qui ont développé des événements hémorragiques majeurs
Délai: à 3 ans
|
à 3 ans
|
|
Pourcentage de participants ayant reçu un traitement anticoagulant prescrit
Délai: après inclusion
|
après inclusion
|
|
Pourcentage de participants qui ont développé des événements cardiovasculaires
Délai: à 3 ans
|
à 3 ans
|
|
Pourcentage de participants décédés de n'importe quelle cause
Délai: à 3 ans
|
à 3 ans
|
|
Pourcentage de participants ayant développé un cancer
Délai: à 3 ans
|
à 3 ans
|
|
Pourcentage de participants ayant développé une insuffisance veineuse (ulcère de jambe)
Délai: à 3 ans
|
à 3 ans
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jean Luc JB BOSSON, MD, University Hospital, Grenoble
- Chaise d'étude: Marie Antoinette SEVESTRE, MD, Amiens University Hospital
Publications et liens utiles
Publications générales
- 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.
- Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.
- Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.
- Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quere I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.
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- DCIC-04-02
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