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

NCT06096051 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2026-03-23

No results posted yet for this study

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

Conditions

  • Intracranial Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Tamara Reiter, PharmD · Methodist Midlothian Medical Center

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-06-17
Completion
2024-06-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096051 on ClinicalTrials.gov