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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096051
Other study ID # 027.PHA.2023.A
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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