Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT05928091 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-16
Last updated
2026-04-30

Condition(s) studied

Hemorrhage

Investigational drug(s) / intervention(s)

Phone call to an expert team

Phone call to an expert team: Patients will be treated as the expert said when the investigator called him

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Effectiveness of bleeding management — Hour 24
    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

Trial sites (15)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05928091 on ClinicalTrials.gov ↗ ← All trials in France