An interventional study of Expert eCRF and Prothrombin Complex Concentrate in Emergency Care for Severe Bleeding While on Anticoagulants, sponsored by Octapharma. Completed at 26 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Octapharma · Not applicable, Interventional, and Other
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
Octapharma is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
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Hemodynamic instability: SBP \< 90 mmHg or SBP decrease
surgery, interventional radiology, endoscopy 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.
Exclusion Criteria:
Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
Other: Prothrombin Complex Concentrate
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 · Other: Prothrombin Complex Concentrate
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
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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