Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Methodist Health System

Status: Enrolling

Conditions: Intracranial Hemorrhage

Treatments: Procedure: Use of fixed-dosed 4F-PCC

Study type: Observational

Funder types: Other

Identifiers

NCT06096051

027.PHA.2023.A

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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