Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
NCT ID: NCT03320603
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
397 participants
INTERVENTIONAL
2017-10-13
2020-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Phase 1
Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
Prothrombin Complex Concentrate
Prothrombin Complex Concentrate given as standard of care
Phase 2
Prospective collection of data on expert data collection tool (expert eCRF reminding recommendations at each step of the management of severe bleeding). Prothrombin Complex Concentrate given as standard of care.
Expert eCRF
An expert eCRF will be used to guide physicians during the management of patients treated with Vitamin K Agonist or Direct Oral Anticoagulant admitted in emergency units for severe bleeding.
Prothrombin Complex Concentrate
Prothrombin Complex Concentrate given as standard of care
Interventions
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Expert eCRF
An expert eCRF will be used to guide physicians during the management of patients treated with Vitamin K Agonist or Direct Oral Anticoagulant admitted in emergency units for severe bleeding.
Prothrombin Complex Concentrate
Prothrombin Complex Concentrate given as standard of care
Eligibility Criteria
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Inclusion Criteria
* Receiving oral anticoagulants (VKA or DOAC)
* With a severe bleeding episode meeting at least one of the following criteria
* External hemorrhage which cannot be controlled by usual means or
* Hemodynamic instability: SBP \< 90 mmHg or SBP decrease
* 40 mmHg from usual SBP or mean BP \< 65 mmHg or any sign of shock or
* Patient requiring a hemostatic procedure in emergency:
surgery, interventional radiology, endoscopy or
* Need for transfusion of packed red blood cells or
* Hemorrhage jeopardizing the vital or functional prognosis:
e.g. intracranial hemorrhage, intraspinal hemorrhage, intraocular or retro-ocular hemorrhage, hemothorax, hemoperitoneum, retroperitoneal hemorrhage, hemopericardium, deep muscle hematoma or compartment syndrome, acute digestive hemorrhage, hemarthrosis.
* Admitted in the participating emergency service
* Accepting the collection of his/her own health-related data
Exclusion Criteria
* Pregnant or nursing woman
* Patient under supervision or legal guardianship
18 Years
ALL
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier d'Avignon
Avignon, , France
Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
Besançon, , France
Clinique Médipole Saint-Roch
Cabestany, , France
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
Caen, , France
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
Caen, , France
Centre Hospitalier Chalon-sur-Saône William Morey
Chalon-sur-Saône, , France
Hôpitaux Civils de Colmar
Colmar, , France
Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
Lyon, , France
Clinique du Tonkin
Lyon, , France
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
Lyon, , France
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
Lyon, , France
Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
Metz, , France
Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
Nantes, , France
Centre Hospitalier de Pau
Pau, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
Reims, , France
Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
Rouen, , France
Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
Strasbourg, , France
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
Strasbourg, , France
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
Strasbourg, , France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, , France
Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
Toulouse, , France
Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
Tours, , France
Centre Hospitalier de Valence
Valence, , France
Groupe Hospitalier de la Haute-Saône Site de Vesoul
Vesoul, , France
Countries
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Other Identifiers
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OPTIPLEX 2
Identifier Type: -
Identifier Source: org_study_id
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