NCT05928091

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Oct 2023Jul 2026

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

June 23, 2023

Last Update Submit

April 27, 2026

Conditions

Hemorrhage

Keywords

anticoagulantshemorrhage

Outcome Measures

Primary Outcomes (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

    Hour 24

Secondary Outcomes (9)

  • Mortality rate all causes

    Inclusion + 3 months

  • Hemostatic efficacy rate

    Hour 24

  • Specific mortality rate related to haemorrhage

    Inclusion + 3 months

  • Rate of new bleeding

    Inclusion + 3 months

  • Thromboembolic events

    Inclusion + 3 months

  • +4 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Doctors will manage bleeding as usual.

Experimental group

EXPERIMENTAL

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

Other: Phone call to an expert team

Interventions

Phone call to an expert teamOTHER

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

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CH Aurillac

Aurillac, 15000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Grenoble

Grenoble, 38000, France

Location

CH Le Puy

Le Puy-en-Velay, 43000, France

Location

Hospice civils de Lyon

Lyon, 69000, France

Location

CH de Montbrison

Montbrison, 42600, France

Location

CH Montluçon

Montluçon, 03000, France

Location

CH de Moulins

Moulins, 03000, France

Location

CHU de Nice

Nice, 06000, France

Location

CHR Orléans

Orléans, 45000, France

Location

La Pitié-Salpétrière

Paris, 75013, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

CHU Tours

Tours, 37000, France

Location

CH de Vichy

Vichy, 03200, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fares MOUSTAFA

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

October 16, 2023

Primary Completion

April 20, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

FR(15)