Evaluating expert opinions in managing severe bleeding for patients on anticoagulants

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

This study is testing if getting advice from experts helps doctors manage severe bleeding better in patients taking blood thinners compared to regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Clermont-Ferrand (Academic / other)
• Locations: 15 sites (Aurillac and 14 other locations)
• Trial ID: NCT05928091 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess whether the involvement of an expert opinion improves the management of patients experiencing severe bleeding while on oral anticoagulants compared to standard management practices. Patients will be randomized into two groups: one receiving traditional management and the other receiving management with expert consultation. The study will follow patients for three months, monitoring for thrombotic events and complications related to hemorrhage. The goal is to determine if expert guidance leads to better outcomes in these critical situations.

Who should consider this trial

Good fit: Ideal candidates include major patients treated with oral anticoagulants who are admitted to an emergency department with suspected major bleeding.

Not a fit: Patients who are pregnant, breastfeeding, or have received parenteral anticoagulants within the last 24 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the management of severe bleeding in patients on anticoagulants, potentially reducing complications and improving patient outcomes.

How similar studies have performed: While the specific approach of utilizing expert opinions in this context may be novel, similar studies have shown that expert consultations can improve clinical decision-making in emergency situations.

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

Where this trial is running

Aurillac and 14 other locations

• CH Aurillac — Aurillac, France (Recruiting)
• CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• CHU Grenoble — Grenoble, France (Recruiting)
• CH Le Puy — Le Puy-en-Velay, France (Recruiting)
• Hospice civils de Lyon — Lyon, France (Recruiting)
• CH de Montbrison — Montbrison, France (Not_yet_recruiting)
• CH Montluçon — Montluçon, France (Not_yet_recruiting)
• CH de Moulins — Moulins, France (Recruiting)
• CHU de Nice — Nice, France (Not_yet_recruiting)
• CHR Orléans — Orléans, France (Recruiting)
• La Pitié-Salpétrière — Paris, France (Not_yet_recruiting)
• CHU de Saint-Etienne — Saint-Étienne, France (Not_yet_recruiting)
• CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
• CHU Tours — Tours, France (Recruiting)
• CH de Vichy — Vichy, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Fares MOUSTAFA — University Hospital, Clermont-Ferrand
• Study coordinator: Lise LACLAUTRE

Conditions Hemorrhage; anticoagulants; hemorrhage