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

Primary Purpose

Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phone call to an expert team
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring anticoagulants, hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Aurillac
  • CHU de Clermont-FerrandRecruiting
  • CHU Grenoble
  • CH Le Puy
  • Hospice civils de Lyon
  • CH Montluçon
  • CH de Moulins
  • CHR Orléans
  • CHU de Saint-Etienne
  • CHU de Toulouse
  • CHU ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Doctors will manage bleeding as usual.

Investigators will call a phone number, and an expert will guide them to manage the bleeding.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality rate all causes
Mortality rate all causes after 3 months
Hemostatic efficacy rate
Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Specific mortality rate related to haemorrhage
Specific mortality rate related to haemorrhage after 3 months
Rate of new bleeding
Rate of new bleeding after 3 months
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
Duration of hospital stay
Duration of hospital stay over the entire 3-month follow-up
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.
Rate of avoided and avoidable reversions
Rate of avoided and avoidable reversions
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)

Full Information

First Posted
June 23, 2023
Last Updated
October 17, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05928091
Brief Title
Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
Acronym
BANET
Official Title
Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
anticoagulants, hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Doctors will manage bleeding as usual.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Investigators will call a phone number, and an expert will guide them to manage the bleeding.
Intervention Type
Other
Intervention Name(s)
Phone call to an expert team
Intervention Description
Patients will be treated as the expert said when the investigator called him
Primary Outcome Measure Information:
Title
Effectiveness of bleeding management
Description
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
Time Frame
Hour 24
Secondary Outcome Measure Information:
Title
Mortality rate all causes
Description
Mortality rate all causes after 3 months
Time Frame
Inclusion + 3 months
Title
Hemostatic efficacy rate
Description
Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Time Frame
Hour 24
Title
Specific mortality rate related to haemorrhage
Description
Specific mortality rate related to haemorrhage after 3 months
Time Frame
Inclusion + 3 months
Title
Rate of new bleeding
Description
Rate of new bleeding after 3 months
Time Frame
Inclusion + 3 months
Title
Thromboembolic events
Description
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
Time Frame
Inclusion + 3 months
Title
Duration of hospital stay
Description
Duration of hospital stay over the entire 3-month follow-up
Time Frame
Inclusion + 3 months
Title
Changes in haemostasis values
Description
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.
Time Frame
Hour 6
Title
Rate of avoided and avoidable reversions
Description
Rate of avoided and avoidable reversions
Time Frame
Hour 24
Title
Deadlines for implementing a reversion
Description
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)
Time Frame
Hour 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fares MOUSTAFA
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Aurillac
City
Aurillac
ZIP/Postal Code
15000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Duchenne
Phone
0471468241
Email
j.duchenne@ch-aurillac.fr
First Name & Middle Initial & Last Name & Degree
Jonathan Duchenne
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Fares Moustafa
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Viglino
Phone
0476766784
Email
dviglino@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Damien Viglino
Facility Name
CH Le Puy
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alizée Gagnaire
Phone
0471043104
Email
alizee.gagnaire@gmail.com
First Name & Middle Initial & Last Name & Degree
Alizée Gagnaire
Facility Name
Hospice civils de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Tazarourte
Phone
0472110041
Email
Karim.tazarourte@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Karim Tazarourte
Facility Name
CH Montluçon
City
Montluçon
ZIP/Postal Code
03000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Loiseau
Phone
0470027210
Email
s.loiseau@ch-montlucon.fr
First Name & Middle Initial & Last Name & Degree
Sébastien Loiseau
Facility Name
CH de Moulins
City
Moulins
ZIP/Postal Code
03000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Thomas
Email
f.thomas@ch-moulins-yzeure.fr
First Name & Middle Initial & Last Name & Degree
Fabien Thomas
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Garrouste
Email
vincent.garrouste@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Vincent Garrouste
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Viallon
Phone
0477829406
Email
Alain.viallon@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Alain Viallon
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Balen
Email
balen.f@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Balen
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Moumneh
Phone
0247478109
Email
t.moumneh@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Thomas Moumneh

12. IPD Sharing Statement

Learn more about this trial

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

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