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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
397
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 given as standard of care
Proper Use of PCC Proportion
Proportion of patients for whom the rules of proper use of PCC have been respected
Time frame: 20 months
Time to Death
Time to death
Time frame: 20 months
Survival Rate
Survival rate
Time frame: 20 months
Proportion of Patients with Poor Outcome
Proportion of patients with poor outcome: comparison of phase 1 and phase 2
Time frame: 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.
Time frame: 20 months
Proportion of Patients with Seroconversion
Proportion of Patients with Seroconversion
Time frame: 20 months
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