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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01684-37 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Doctors will manage bleeding as usual. | |
| Experimental group | Experimental | Investigators will call a phone number, and an expert will guide them to manage the bleeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone call to an expert team | Other | Patients will be treated as the expert said when the investigator called him |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fares MOUSTAFA | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Aurillac | Aurillac | 15000 | France | |||
| CHU de Clermont-Ferrand |
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Centers will be randomized in two arms :
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| 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 |
| Hour 24 |
| Clermont-Ferrand |
| 63000 |
| France |
| CHU Grenoble | Grenoble | 38000 | France |
| CH Le Puy | Le Puy-en-Velay | 43000 | France |
| Hospice civils de Lyon | Lyon | 69000 | France |
| CH de Montbrison | Montbrison | 42600 | France |
| CH Montluçon | Montluçon | 03000 | France |
| CH de Moulins | Moulins | 03000 | France |
| CHU de Nice | Nice | 06000 | France |
| CHR Orléans | Orléans | 45000 | France |
| La Pitié-Salpétrière | Paris | 75013 | France |
| CHU de Saint-Etienne | Saint-Etienne | 42000 | France |
| CHU de Toulouse | Toulouse | 31000 | France |
| CHU Tours | Tours | 37000 | France |
| CH de Vichy | Vichy | 03200 | France |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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