Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants

Study Overview
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Brief Summary
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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

Official Title
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Administration of PCC in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants: Impact of an Expert ECRF on Adherence to Rules of Proper Use and Outcome

Conditions
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Emergency Care for Severe Bleeding While on Anticoagulants

Intervention / Treatment
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* Other: Expert eCRF
* Other: Prothrombin Complex Concentrate


Participation Criteria
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Eligibility Criteria
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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 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: Patient participating in another interventional study Pregnant or nursing woman Patient under supervision or legal guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 1<br>Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care. | Other: Prothrombin Complex Concentrate<br>* Prothrombin Complex Concentrate given as standard of care<br>|
| Other: Phase 2<br>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. | Other: Expert eCRF<br>* 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.<br>Other: Prothrombin Complex Concentrate<br>* Prothrombin Complex Concentrate given as standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death | Time to death | 20 months | 
| Survival Rate | Survival rate | 20 months | 
| 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 |