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HemorrhageBANETNCT05928091

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

A study testing Phone call to an expert team in people with Hemorrhage, run by University Hospital, Clermont-Ferrand at 15 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhage
What is being tested?
Phone call to an expert team
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
15 sitesFrance
Study dates
16 Oct 2023to 20 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CH Aurillac

    Aurillac, 15000

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • CHU Grenoble

    Grenoble, 38000

  • CH Le Puy

    Le Puy-en-Velay, 43000

  • Hospice civils de Lyon

    Lyon, 69000

  • CH de Montbrison

    Montbrison, 42600

  • CH Montluçon

    Montluçon, 03000

  • CH de Moulins

    Moulins, 03000

  • CHU de Nice

    Nice, 06000

  • CHR Orléans

    Orléans, 45000

  • La Pitié-Salpétrière

    Paris, 75013

  • CHU de Saint-Etienne

    Saint-Etienne, 42000

  • CHU de Toulouse

    Toulouse, 31000

  • CHU Tours

    Tours, 37000

  • CH de Vichy

    Vichy, 03200

Other trials in France

About this study

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.
Read more

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.

Conditions
Hemorrhage
Being tested
Phone call to an expert team
Keywords
anticoagulants, hemorrhage
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phone call to an expert teamOther

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

Study groups in NCT05928091
Study groupRoleWhat they receive
Control groupNo interventionDoctors will manage bleeding as usual.
Experimental groupExperimentalInvestigators will call a phone number, and an expert will guide them to manage the bleeding.
Receives: Other: Phone call to an expert team

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of bleeding management

    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

    Measured: Hour 24

Secondary outcomes (9)

  1. Mortality rate all causes

    Mortality rate all causes after 3 months

    Measured: Inclusion + 3 months

  2. Hemostatic efficacy rate

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

    Measured: Hour 24

  3. Specific mortality rate related to haemorrhage

    Specific mortality rate related to haemorrhage after 3 months

    Measured: Inclusion + 3 months

  4. Rate of new bleeding

    Rate of new bleeding after 3 months

    Measured: Inclusion + 3 months

  5. Thromboembolic events

    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

    Measured: Inclusion + 3 months

  6. Duration of hospital stay

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

    Measured: Inclusion + 3 months

  7. Changes in haemostasis values

    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.

    Measured: Hour 6

  8. Rate of avoided and avoidable reversions

    Rate of avoided and avoidable reversions

    Measured: Hour 24

  9. Deadlines for implementing a reversion

    • 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)

    Measured: Hour 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start16 Oct 2023
  3. Primary completion20 Apr 2026
  4. Study completion20 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Centers will be randomized in two arms : * control group : each center will manage hemorrhage of participation as they usually did * interventional group : management of hemorrhage will be guided by the expert team
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928091
Sponsor's protocol ID
PHRC IR 2019 BANET
Other IDs
2021-A01684-37
Acronym
BANET
Status last verified
Apr 2026
First submitted
23 Jun 2023
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Phone call to an expert team in people with Hemorrhage, run by University Hospital, Clermont-Ferrand at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of bleeding management (time frame: Hour 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05928091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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