Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
NCT ID: NCT05928091
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-10-16
2027-12-31
Brief Summary
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• 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
NONE
Study Groups
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Control group
Doctors will manage bleeding as usual.
No interventions assigned to this group
Experimental group
Investigators will call a phone number, and an expert will guide them to manage the bleeding.
Phone call to an expert team
Patients will be treated as the expert said when the investigator called him
Interventions
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Phone call to an expert team
Patients will be treated as the expert said when the investigator called him
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient under guardianship, curatorship or safeguard of justice
* Administration within the last 24 hours of parenteral anticoagulant.
* Refusal to participate
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Fares MOUSTAFA
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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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-Etienne, , France
CHU de Toulouse
Toulouse, , France
CHU Tours
Tours, , France
CH de Vichy
Vichy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A01684-37
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC IR 2019 BANET
Identifier Type: -
Identifier Source: org_study_id
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