Anticoagulants, Elderly, Pulmonary Embolism
Conditions
Keywords
elderly patients, Pulmonary embolism, Anticoagulant treatments
Brief summary
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.
Interventions
OTHER4 blood samples
PK and / or PD measurements during hospitalization
Sponsors
Ministry of Health, France
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic pulmonary embolism confirmed by objective paraclinical examination with or without DVT associated * confirmation of pulmonary embolism within 3 days * Administration possible according to the recommended dosages of anticoagulant treatment : (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) * Indication of anticoagulant treatment for at least 6 months
Exclusion criteria
* on therapeutic dose of anticoagulant treatment over 72 hours * indication to therapeutic dose of anticoagulant treatment for another reason. * Inability for whatever reasons, to prescribe recommended anticoagulant treatment * PE treatment on heparin-induced thrombocytopenia requiring argatroban, lepirudin or danaparoid treatment, * ongoing bleeding * PE occurring despite well conducted anticoagulant treatment * Contraindications to recommended dose of anticoagulant treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding defined by the International Society of Thrombosis & Haemostasis | at 6 months | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant non-major bleeding | at 6 months | 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 |
| Recurrent pulmonary embolism | at 6 months | confirmed by CT scan or ventilation/perfusion lung scan |
| Deep vein thrombosis (recurrence or new) | at 6 months | confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan |
| Arterial cardiovascular events | at 6 months | * 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. |
| Death | at 6 months | — |
Countries
France
Outcome results
None listed