An observational study in Elderly, Pulmonary Embolism and Anticoagulants, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 20 sites in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
753 studies on the registry are indexed under Pulmonary Embolism; 157 are open to participants now.
This study's enrollment of 1,500 is above the median of 370 across 332 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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patients older than 75 years receiving an anticoagulant treatment (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) for a symptomatic and confirmed pulmonary embolism
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE
Other: 4 blood samples
PK and / or PD measurements during hospitalization
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
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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