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The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or experts' consensus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Other | Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care. |
|
| Phase 2 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expert eCRF | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proper Use of PCC Proportion | Proportion of patients for whom the rules of proper use of PCC have been respected | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Death | Time to death | 20 months |
| Survival Rate | Survival rate | 20 months |
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Inclusion Criteria:
Adult patients (≥ 18 years old)
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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Avignon | Avignon | 84000 | France | |||
| Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 12, 2026 | |
| Reset | Mar 31, 2026 | |
| Release | Apr 24, 2026 |
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| Prothrombin Complex Concentrate | Other | Prothrombin Complex Concentrate given as standard of care |
|
| Proportion of Patients with Poor Outcome | Proportion of patients with poor outcome: comparison of phase 1 and phase 2 | 20 months |
| Predictors of Poor Outcome | Predictors or poor outcome. Potential predictors of poor outcome will be the time from first symptom to admission, the time from first symptom to Prothrombin Complex Concentrate administration, adherence to recommendations regarding proper use of Prothrombin Complex Concentrate, concomitant antiplatelets treatment, medical history or concomitant diseases (cardiac failure, coronary disease, renal failure, diabetes, severe COPD, cancer). For intracranial hemorrhages predictors will include the volume of intracranial hematoma. | 20 months |
| Proportion of Patients with Seroconversion | Proportion of Patients with Seroconversion | 20 months |
| Besançon |
| 25030 |
| France |
| Clinique Médipole Saint-Roch | Cabestany | 66330 | France |
| Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation | Caen | 14033 | France |
| Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences | Caen | 14033 | France |
| Centre Hospitalier Chalon-sur-Saône William Morey | Chalon-sur-Saône | 71321 | France |
| Hôpitaux Civils de Colmar | Colmar | 68024 | France |
| Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences | Lyon | 69003 | France |
| Clinique du Tonkin | Lyon | 69100 | France |
| Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation | Lyon | 69310 | France |
| Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences | Lyon | 69310 | France |
| Centre Hospitalier Régional Metz-Thionville Hôpital Mercy | Metz | 57530 | France |
| Centre Hospitalier Universitaire de Nantes Hôtel-Dieu | Nantes | 44000 | France |
| Centre Hospitalier de Pau | Pau | 64000 | France |
| Centre Hospitalier de Perpignan | Perpignan | 66000 | France |
| Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche | Reims | 51092 | France |
| Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou | Rennes | 35033 | France |
| Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle | Rouen | 76000 | France |
| Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences | Strasbourg | 67000 | France |
| Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation | Strasbourg | 67200 | France |
| Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences | Strasbourg | 67200 | France |
| Hôpital d'Instruction des Armées Sainte-Anne | Toulon | 83000 | France |
| Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil | Toulouse | 31400 | France |
| Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau | Tours | 37170 | France |
| Centre Hospitalier de Valence | Valence | 26000 | France |
| Groupe Hospitalier de la Haute-Saône Site de Vesoul | Vesoul | 70000 | France |
| Reset | May 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2026 | Mar 31, 2026 | |||
| Apr 24, 2026 | May 15, 2026 |
| ID | Term |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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