Status:
COMPLETED
Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
Lead Sponsor:
Octapharma
Conditions:
Emergency Care for Severe Bleeding While on Anticoagulants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 adher...
Eligibility Criteria
Inclusion
- 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
- Patient participating in another interventional study
- Pregnant or nursing woman
- Patient under supervision or legal guardianship
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT03320603
Start Date
October 13 2017
End Date
December 20 2020
Last Update
July 27 2021
Active Locations (26)
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1
Centre Hospitalier d'Avignon
Avignon, France, 84000
2
Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
Besançon, France, 25030
3
Clinique Médipole Saint-Roch
Cabestany, France, 66330
4
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
Caen, France, 14033