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

Last updated: February 21, 2025
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

Phone call to an expert team

Clinical Study ID

NCT05928091
PHRC IR 2019 BANET
2021-A01684-37
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major patient treated with oral anticoagulants, admitted in an emergency department

  • For suspected major bleeding defined according to the criteria of the InternationalSociety of Thrombosis and Haemostasis

  • Able to give informed consent to participate in research or, in the event of anemergency, to take charge of a reference person

  • Affiliated to a Social Security scheme.

Exclusion

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

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Phone call to an expert team
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • CH Aurillac

    Aurillac, 15000
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble, 38000
    France

    Active - Recruiting

  • CH Le Puy

    Le Puy-en-Velay, 43000
    France

    Active - Recruiting

  • Hospice civils de Lyon

    Lyon, 69000
    France

    Active - Recruiting

  • CH de Montbrison

    Montbrison, 42600
    France

    Site Not Available

  • CH Montluçon

    Montluçon, 03000
    France

    Site Not Available

  • CH de Moulins

    Moulins, 03000
    France

    Active - Recruiting

  • CHU de Nice

    Nice, 06000
    France

    Site Not Available

  • CHR Orléans

    Orléans, 45000
    France

    Active - Recruiting

  • La Pitié-Salpétrière

    Paris, 75013
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Étienne, 42000
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse, 31000
    France

    Site Not Available

  • CHU Tours

    Tours, 37000
    France

    Active - Recruiting

  • CH de Vichy

    Vichy, 03200
    France

    Site Not Available

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