Clinical trial NCT05928091: Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
Official title: Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhage
Keywords: anticoagulants
hemorrhage
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 team
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effectiveness of bleeding management
timeFrame: Hour 24
Secondary outcomes:
measure: Mortality rate all causes
timeFrame: Inclusion + 3 months
measure: Hemostatic efficacy rate
timeFrame: Hour 24
measure: Specific mortality rate related to haemorrhage
timeFrame: Inclusion + 3 months
measure: Rate of new bleeding
timeFrame: Inclusion + 3 months
measure: Thromboembolic events
timeFrame: Inclusion + 3 months
measure: Duration of hospital stay
timeFrame: Inclusion + 3 months
measure: Changes in haemostasis values
timeFrame: Hour 6
measure: Rate of avoided and avoidable reversions
timeFrame: Hour 24
measure: Deadlines for implementing a reversion
timeFrame: Hour 24
Other outcomes:
Locations:
city: Aurillac
country: France
facility: CH Aurillac
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Puy-en-Velay
country: France
facility: CH Le Puy
city: Lyon
country: France
facility: Hospice civils de Lyon
city: Montbrison
country: France
facility: CH de Montbrison
city: Montluçon
country: France
facility: CH Montluçon
city: Moulins
country: France
facility: CH de Moulins
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: La Pitié-Salpétrière
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU Tours
city: Vichy
country: France
facility: CH de Vichy
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Fares MOUSTAFA
role: PRINCIPAL_INVESTIGATOR
References: