The goal of this randomized clinical trial is to evaluate the impact of an expert opinion during the management of patients with severe bleeding on oral anticoagulants. The main question it aims to answer is : • Does an expert help of decision during the management of patients with severe bleeding is superior to classic management ? The centers will be randomized in one of the two groups : control group and interventional group. Patients will be followed for 3 months. At their inclusion they will be managed in conformity of the randomisation of their center. They will be followed at hour 0 + 6 , H0+24 and at the end of hospitalization. After 3 months, they will be called to assess the occurrence of thrombotic events ou hemorrhage complications. Researchers will compare the classic management versus the management with an expert opinion to see if the expert opinion is superior to classic management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Patients will be treated as the expert said when the investigator called him
CH Aurillac
Aurillac, France
RECRUITINGCHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Grenoble
Grenoble, France
RECRUITINGCH Le Puy
Le Puy-en-Velay, France
RECRUITINGHospice civils de Lyon
Lyon, France
RECRUITINGCH de Montbrison
Montbrison, France
NOT_YET_RECRUITINGCH Montluçon
Montluçon, France
NOT_YET_RECRUITINGCH de Moulins
Moulins, France
RECRUITINGCHU de Nice
Nice, France
NOT_YET_RECRUITINGCHR Orléans
Orléans, France
RECRUITING...and 5 more locations
Effectiveness of bleeding management
The effectiveness of the management of bleeding will be evaluated with a rate of compliance with the recommendations in the event of major bleeding under oral anticoagulants
Time frame: Hour 24
Mortality rate all causes
Mortality rate all causes after 3 months
Time frame: Inclusion + 3 months
Hemostatic efficacy rate
Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Time frame: Hour 24
Specific mortality rate related to haemorrhage
Specific mortality rate related to haemorrhage after 3 months
Time frame: Inclusion + 3 months
Rate of new bleeding
Rate of new bleeding after 3 months
Time frame: Inclusion + 3 months
Thromboembolic events
Major thrombosis including symptomatic proximal venous thrombosis, symptomatic or non-symptomatic pulmonary embolism, ischemic vascular accident, myocardial infarction, cerebral thrombophlebitis, mesenteric portal thrombosis at 3 months
Time frame: Inclusion + 3 months
Duration of hospital stay
Duration of hospital stay over the entire 3-month follow-up
Time frame: Inclusion + 3 months
Changes in haemostasis values
Rate of correction of haemostasis disorders at 6 hours post-reversion defined by an INR of less than 1.5 for Vitamin K Antagnist and normalization of activated partial thromboplastin time, prothrombin time, anti-Xa activity according to local normal values.
Time frame: Hour 6
Rate of avoided and avoidable reversions
Rate of avoided and avoidable reversions
Time frame: Hour 24
Deadlines for implementing a reversion
* Comparison of the time between the arrival of the patient in the emergency room and the implementation of the reversal * Comparison of the time between the patient's arrival in the emergency room and the performance of diagnostic imaging, particularly cerebral * Comparison of the time between the patient's arrival in the emergency room and the performance of a haemostatic procedure (interventional radiology, surgery, fibroscopy)
Time frame: Hour 24
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