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

October 17, 2023 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Aurillac, France, 15000
        • Not yet recruiting
        • CH Aurillac
        • Contact:
        • Principal Investigator:
          • Jonathan Duchenne
      • Clermont-Ferrand, France, 63000
      • Grenoble, France, 38000
        • Not yet recruiting
        • CHU Grenoble
        • Principal Investigator:
          • Damien Viglino
        • Contact:
      • Le Puy-en-Velay, France, 43000
        • Not yet recruiting
        • CH Le puy
        • Contact:
        • Principal Investigator:
          • Alizée Gagnaire
      • Lyon, France, 69000
        • Not yet recruiting
        • Hospice Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Karim Tazarourte
      • Montluçon, France, 03000
        • Not yet recruiting
        • CH Montluçon
        • Contact:
        • Principal Investigator:
          • Sébastien Loiseau
      • Moulins, France, 03000
      • Orléans, France, 45000
      • Saint-Étienne, France, 42000
        • Not yet recruiting
        • CHU de Saint-Etienne
        • Contact:
        • Principal Investigator:
          • Alain Viallon
      • Toulouse, France, 31000
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Frédéric Balen
      • Tours, France, 37000
        • Recruiting
        • Chu Tours
        • Contact:
        • Principal Investigator:
          • Thomas Moumneh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Doctors will manage bleeding as usual.
Experimental: Experimental group
Investigators will call a phone number, and an expert will guide them to manage the bleeding.
Other: Phone call to an expert team
Patients will be treated as the expert said when the investigator called him

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of bleeding management
Time Frame: 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
Hour 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate all causes
Time Frame: Inclusion + 3 months
Mortality rate all causes after 3 months
Inclusion + 3 months
Specific mortality rate related to haemorrhage
Time Frame: Inclusion + 3 months
Specific mortality rate related to haemorrhage after 3 months
Inclusion + 3 months
Rate of new bleeding
Time Frame: Inclusion + 3 months
Rate of new bleeding after 3 months
Inclusion + 3 months
Thromboembolic events
Time Frame: Inclusion + 3 months
Major thrombosis including symptomatic proximal venous thrombosis, symptomatic or non-symptomatic pulmonary embolism, ischemic vascular accident, myocardial infarction, cerebral thrombophlebitis, mesenteric portal thrombosis at 3 months
Inclusion + 3 months
Duration of hospital stay
Time Frame: Inclusion + 3 months
Duration of hospital stay over the entire 3-month follow-up
Inclusion + 3 months
Hemostatic efficacy rate
Time Frame: Hour 24
Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Hour 24
Changes in haemostasis values
Time Frame: Hour 6
Rate of correction of haemostasis disorders at 6 hours post-reversion defined by an INR of less than 1.5 for Vitamin K Antagnist and normalization of activated partial thromboplastin time, prothrombin time, anti-Xa activity according to local normal values.
Hour 6
Rate of avoided and avoidable reversions
Time Frame: Hour 24
Rate of avoided and avoidable reversions
Hour 24
Deadlines for implementing a reversion
Time Frame: Hour 24
  • Comparison of the time between the arrival of the patient in the emergency room and the implementation of the reversal
  • Comparison of the time between the patient's arrival in the emergency room and the performance of diagnostic imaging, particularly cerebral
  • Comparison of the time between the patient's arrival in the emergency room and the performance of a haemostatic procedure (interventional radiology, surgery, fibroscopy)
Hour 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Fares MOUSTAFA, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC IR 2019 BANET
  • 2021-A01684-37 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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