Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.

Conditions
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Hemorrhage

Intervention / Treatment
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* Other: Phone call to an expert team


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient treated with oral anticoagulants, admitted in an emergency department For suspected major bleeding defined according to the criteria of the International Society of Thrombosis and Haemostasis Able to give informed consent to participate in research or, in the event of an emergency, to take charge of a reference person Affiliated to a Social Security scheme. Exclusion Criteria: Pregnant or breastfeeding women Patient under guardianship, curatorship or safeguard of justice Administration within the last 24 hours of parenteral anticoagulant. Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Centers will be randomized in two arms : control group : each center will manage hemorrhage of participation as they usually did interventional group : management of hemorrhage will be guided by the expert team
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Doctors will manage bleeding as usual. | |
| Experimental: Experimental group<br>Investigators will call a phone number, and an expert will guide them to manage the bleeding. | Other: Phone call to an expert team<br>* Patients will be treated as the expert said when the investigator called him<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Hour 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate all causes | Mortality rate all causes after 3 months | Inclusion + 3 months | 
| Hemostatic efficacy rate | Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee | Hour 24 | 
| Specific mortality rate related to haemorrhage | Specific mortality rate related to haemorrhage after 3 months | Inclusion + 3 months | 
| Rate of new bleeding | Rate of new bleeding after 3 months | 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 | Inclusion + 3 months | 
| Duration of hospital stay | Duration of hospital stay over the entire 3-month follow-up | 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. | Hour 6 | 
| Rate of avoided and avoidable reversions | Rate of avoided and avoidable reversions | 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) | Hour 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulants, hemorrhage