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

Hemorrhage Clinical Trial

— BANET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928091
• Other study ID #: PHRC IR 2019 BANET
• Secondary ID: 2021-A01684-37
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Other:
• Phone call to an expert team
Patients will be treated as the expert said when the investigator called him

Locations

Country	Name	City	State
France	CH Aurillac	Aurillac
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	CH Le Puy	Le Puy-en-Velay
France	Hospice civils de Lyon	Lyon
France	CH de Montbrison	Montbrison
France	CH Montluçon	Montluçon
France	CH de Moulins	Moulins
France	CHU de Nice	Nice
France	CHR Orléans	Orléans
France	La Pitié-Salpétrière	Paris
France	CHU de Saint-Etienne	Saint-Étienne
France	CHU de Toulouse	Toulouse
France	CHU Tours	Tours
France	CH de Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hour 24
Secondary	Mortality rate all causes	Mortality rate all causes after 3 months	Inclusion + 3 months
Secondary	Hemostatic efficacy rate	Hemostatic efficacy rate at 24 hours evaluated by an independent blinded evaluation committee	Hour 24
Secondary	Specific mortality rate related to haemorrhage	Specific mortality rate related to haemorrhage after 3 months	Inclusion + 3 months
Secondary	Rate of new bleeding	Rate of new bleeding after 3 months	Inclusion + 3 months
Secondary	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	Inclusion + 3 months
Secondary	Duration of hospital stay	Duration of hospital stay over the entire 3-month follow-up	Inclusion + 3 months
Secondary	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.	Hour 6
Secondary	Rate of avoided and avoidable reversions	Rate of avoided and avoidable reversions	Hour 24
Secondary	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)	Hour 24