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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05928091

Collaborator

(none)

1,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

90.9

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage	Other: Phone call to an expert team	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 teamCenters 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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality rate all causes [Inclusion + 3 months]
Mortality rate all causes after 3 months
Hemostatic efficacy rate [Hour 24]
Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee
Specific mortality rate related to haemorrhage [Inclusion + 3 months]
Specific mortality rate related to haemorrhage after 3 months
Rate of new bleeding [Inclusion + 3 months]
Rate of new bleeding after 3 months
Thromboembolic events [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
Duration of hospital stay [Inclusion + 3 months]
Duration of hospital stay over the entire 3-month follow-up
Changes in haemostasis values [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.
Rate of avoided and avoidable reversions [Hour 24]
Rate of avoided and avoidable reversions
Deadlines for implementing a reversion [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Aurillac	Aurillac	France	15000
2	CHU de Clermont-Ferrand	Clermont-Ferrand	France	63000
3	CHU Grenoble	Grenoble	France	38000
4	CH Le Puy	Le Puy-en-Velay	France	43000
5	Hospice civils de Lyon	Lyon	France	69000
6	CH Montluçon	Montluçon	France	03000
7	CH de Moulins	Moulins	France	03000
8	CHR Orléans	Orléans	France	45000
9	CHU de Saint-Etienne	Saint-Étienne	France	42000
10	CHU de Toulouse	Toulouse	France	31000
11	CHU Tours	Tours	France	37000

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT05928091

Other Study ID Numbers:

PHRC IR 2019 BANET
2021-A01684-37

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

anticoagulants

hemorrhage

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Jul 6, 2023