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Studies

Interventional Active not recruiting

NCT05928091 on ClinicalTrials.gov

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

  • Sponsor: Centre Hospitalier Universitaire de Clermont-Ferrand
  • Enrollment: 1000 (Estimated)
  • Study start: 2023-10-16 (Actual)
  • Primary completion: 2026-04-20 (Actual)
  • Study completion: 2026-07-20 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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
  • Masking: None
  • PrimaryPurpose: 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.

Conditions

  • Hemorrhage

Intervention / Treatment

  • Other: Phone call to an expert team

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

Countries

France

Locations and Investigators

  • 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-Etienne, France
  • CHU de Toulouse, Toulouse, France
  • CHU Tours, Tours, France
  • CH de Vichy, Vichy, France

Study Officials