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

Intracranial Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096051
• Other study ID #: 027.PHA.2023.A
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: July 13, 2024

Study information

• Verified date: August 2023
• Source: Methodist Health System
• Contact: Bethany Brauer, MPH
• Phone: 214-947-1281
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 13, 2024
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tenny S, Thorell W. Intracranial Hemorrhage. 2023 Feb 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470242/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine safety and effectiveness of 4F-PCC	fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.	12 hours