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NCT Number: NCT05928091

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Aurillac, Aurillac, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone call to an expert team

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality rate all causes

    Time frame: Inclusion + 3 months

    Mortality rate all causes after 3 months

  2. Hemostatic efficacy rate

    Time frame: Hour 24

    Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee

  3. Specific mortality rate related to haemorrhage

    Time frame: Inclusion + 3 months

    Specific mortality rate related to haemorrhage after 3 months

  4. Rate of new bleeding

    Time frame: Inclusion + 3 months

    Rate of new bleeding after 3 months

  5. 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

  6. Duration of hospital stay

    Time frame: Inclusion + 3 months

    Duration of hospital stay over the entire 3-month follow-up

  7. 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.

  8. Rate of avoided and avoidable reversions

    Time frame: Hour 24

    Rate of avoided and avoidable reversions

  9. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: BANET

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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