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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Page 1 of 1 (1 locations)

1

Methodist Dallas Medical Center

Dallas, Texas, United States, 75203