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OpenTrials
Completed

NCT Number: NCT06096051

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

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

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Key information

Conditions

Intracranial Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of fixed-dosed 4F-PCC

Procedure

Determine if fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.

Primary outcomes

  1. Determine safety and effectiveness of 4F-PCC

    Time frame: 12 hours

    fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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