Evaluation of the Impact of an Expert Opinion During the Management of Patients with Severe Bleeding on Oral Anticoagulants.
- Conditions
- Hemorrhage
- Interventions
- Other: Phone call to an expert team
- Registration Number
- NCT05928091
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- Pregnant or breastfeeding women
- Patient under guardianship, curatorship or safeguard of justice
- Administration within the last 24 hours of parenteral anticoagulant.
- Refusal to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Phone call to an expert team Investigators will call a phone number, and an expert will guide them to manage the bleeding.
- Primary Outcome Measures
Name Time Method Effectiveness of bleeding management Hour 24 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
- Secondary Outcome Measures
Name Time Method Rate of new bleeding Inclusion + 3 months Rate of new bleeding after 3 months
Hemostatic efficacy rate Hour 24 Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Specific mortality rate related to haemorrhage Inclusion + 3 months Specific mortality rate related to haemorrhage after 3 months
Changes in haemostasis values Hour 6 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.
Deadlines for implementing a reversion Hour 24 * 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)Thromboembolic events Inclusion + 3 months 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
Mortality rate all causes Inclusion + 3 months Mortality rate all causes after 3 months
Duration of hospital stay Inclusion + 3 months Duration of hospital stay over the entire 3-month follow-up
Rate of avoided and avoidable reversions Hour 24 Rate of avoided and avoidable reversions
Trial Locations
- Locations (15)
CH Aurillac
🇫🇷Aurillac, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Grenoble
🇫🇷Grenoble, France
CH Le Puy
🇫🇷Le Puy-en-Velay, France
Hospice civils de Lyon
🇫🇷Lyon, France
CH de Montbrison
🇫🇷Montbrison, France
CH Montluçon
🇫🇷Montluçon, France
CH de Moulins
🇫🇷Moulins, France
CHU de Nice
🇫🇷Nice, France
CHR Orléans
🇫🇷Orléans, France
La Pitié-Salpétrière
🇫🇷Paris, France
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU Tours
🇫🇷Tours, France
CH de Vichy
🇫🇷Vichy, France