Intracranial Hemorrhage
Conditions
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.
Interventions
PROCEDUREUse of fixed-dosed 4F-PCC
Determine if fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.
Sponsors
Methodist Health System
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine safety and effectiveness of 4F-PCC | 12 hours | fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTamara Reiter, PharmD
Methodist Midlothian Medical Center
Outcome results
None listed