RecruitingNot ApplicableNCT05928091

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

1,000 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • Pregnant or breastfeeding women
  • Patient under guardianship, curatorship or safeguard of justice
  • Administration within the last 24 hours of parenteral anticoagulant.
  • Refusal to participate

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Interventions

OTHERPhone call to an expert team

Patients will be treated as the expert said when the investigator called him


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-Etienne, France

CHU de Toulouse

Toulouse, France

CHU Tours

Tours, France

CH de Vichy

Vichy, France

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NCT05928091


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