Status:
UNKNOWN
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Lead Sponsor:
Methodist Health System
Conditions:
Intracranial Hemorrhage
Eligibility:
All Genders
18-75 years
Brief Summary
Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence o...
Detailed Description
The authors found that AC use preinjury was associated with ICH progression, immediate neurosurgery intervention, and death after initial scan. AC use has also been associated with worse functional ou...
Eligibility Criteria
Inclusion
- • ≥18 years of age
- ICH (traumatic and spontaneous)
- Administration of at least one dose of 4F-PCC
- Admitted to the MHS between July 1, 2018 and May 30, 2023
- Rivaroxaban or apixaban use prior to admission
Exclusion
- • Warfarin or dabigatran use prior to admission
- Prisoners
- Pregnancy
- \<18 years of age
Key Trial Info
Start Date :
July 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 13 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06096051
Start Date
July 13 2023
End Date
July 13 2024
Last Update
October 23 2023
Active Locations (1)
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1
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203