Clincosm LogoSign in Get a demo

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

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06096051
Collaborator
(none)
100
Enrollment
1
Location
12
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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 of traumatic brain injury (TBI) is nearly 1.7 million annually

Condition or Disease Intervention/Treatment Phase
  • Procedure: Use of fixed-dosed 4F-PCC

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Actual Study Start Date :
Jul 13, 2023
Anticipated Primary Completion Date :
Jul 13, 2024
Anticipated Study Completion Date :
Jul 13, 2024

Outcome Measures

Primary Outcome Measures

  1. Determine safety and effectiveness of 4F-PCC [12 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Tamara Reiter, PharmD, Methodist Midlothian Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06096051
Other Study ID Numbers:
  • 027.PHA.2023.A
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intracranial Hemorrhages
Hemorrhage

Study Results

No Results Posted as of Oct 23, 2023