The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years. So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants). This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450. Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.
Study Type
OBSERVATIONAL
Enrollment
1,500
PK and / or PD measurements during hospitalization
CHU d'Angers
Angers, France
Hôpital Universitaire Jean Minjoz
Besançon, France
CHU de Brest
Brest, France
Clinique du Parc - Castelnau Le Lez
Castelnau-le-Lez, France
CHU Gabriel Montpied
Clermont-Ferrand, France
Hôpitaux Universitaires Louis Mourier Paris Nord
Colombes, France
CHU de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CHU de Limoges
Limoges, France
CHU de Montpellier
Montpellier, France
...and 10 more locations
Major bleeding defined by the International Society of Thrombosis & Haemostasis
* Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells., * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, * Fatal bleeding
Time frame: at 6 months
Clinically relevant non-major bleeding
defined by: * Subcutaneous hematoma spontaneous over 25 cm2 * Spontaneous epistaxis for more than 5 minutes * Spontaneous or after urinary catheter hematuria for more than 24 hours * Significant rectal bleeding * Gingival bleeding for more than 5 minutes * Bleeding requiring hospitalization and / or a hemostatic action
Time frame: at 6 months
Recurrent pulmonary embolism
confirmed by CT scan or ventilation/perfusion lung scan
Time frame: at 6 months
Deep vein thrombosis (recurrence or new)
confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan
Time frame: at 6 months
Arterial cardiovascular events
* Acute coronary syndrom with or without ST-segment elevation * Stroke ischemic or hemorrhagic confirmed by CT scan or magnetic resonance imaging brain * Acute ischemic phenomena (lower limbs, mesenteric ...) confirmed by arterial doppler or arteriography.
Time frame: at 6 months
Death
Time frame: at 6 months
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