NCT06096051

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Use 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.

Timeline

• Start date: 2023-06-13
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2023-10-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States