Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Methodist Health System
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Determine safety and effectiveness of 4F-PCC
Study Overview
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 of traumatic brain injury (TBI) is nearly 1.7 million annually
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 outcomes, and patients are less likely to be discharged home compared to those without AC use prior to injury.6 With increasing prevalence of AC, hospitals are seeing admissions for ICH, making knowledge of optimal AC reversal essential.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• ≥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 Criteria
- •• Warfarin or dabigatran use prior to admission
- •Prisoners
- •Pregnancy
- •<18 years of age
Outcomes
Primary Outcomes
Determine safety and effectiveness of 4F-PCC
Time Frame: 12 hours
fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.
Secondary Outcomes
No secondary outcomes reported