Clinical Trials Logo
  1. Home
  2. Intracranial Hemorrhage
  3. NCT06096051
  4. Details
NCT06096051 Clinical Trial

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
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

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT00795119 - A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children N/A
Completed NCT04062097 - Registration of Idarucizumab for Patients With IntraCranial Hemorrhage
Completed NCT02146040 - Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)
Completed NCT02661672 - INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage N/A
Terminated NCT01463878 - Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study Phase 4
Withdrawn NCT01042574 - The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Phase 4
Recruiting NCT05517109 - Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients N/A
Completed NCT02654015 - INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage N/A
Completed NCT01620203 - Observational Study in Preterm Infants With Intracranial Hemorrhage
Completed NCT01850797 - Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot) N/A
Completed NCT01115660 - Stroke Education Intervention Trial - Pilot N/A
Completed NCT00413946 - Does Erythropoietin Improve Outcome in Very Preterm Infants? Phase 2
Recruiting NCT00505505 - Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy Phase 4
Withdrawn NCT05075486 - Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support N/A
Recruiting NCT05361070 - Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Completed NCT04839770 - MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage N/A
Completed NCT02809651 - Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner N/A
Recruiting NCT04819451 - Application of Magnesium-rich Artificial Cerebrospinal Fluid in Subarachnoid Hemorrhage N/A
Terminated NCT00770718 - Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage Phase 1