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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Hemorrhage

Treatments: Other: Phone call to an expert team

Study type: Interventional

Funder types: Other

Identifiers

NCT05928091

2021-A01684-37 (Other Identifier)

PHRC IR 2019 BANET

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Control group

No Intervention group

Description:

Doctors will manage bleeding as usual.

Experimental group

Experimental group

Description:

Investigators will call a phone number, and an expert will guide them to manage the bleeding.

Treatment:

Other: Phone call to an expert team