NCT06096051

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
Last Updated

March 23, 2026

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

October 17, 2023

Last Update Submit

March 19, 2026

Conditions

Intracranial Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Use of fixed-dosed 4F-PCCPROCEDURE

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients 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

You may qualify if:

  • ≥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

You may not qualify if:

  • Warfarin or dabigatran use prior to admission
  • Prisoners
  • Pregnancy
  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (1)

  • Tenny S, Das JM, Thorell W. Intracranial Hemorrhage Overview. 2024 Feb 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470242/

    PMID: 29262016BACKGROUND

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tamara Reiter, PharmD

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

June 13, 2023

Primary Completion

June 17, 2024

Study Completion

June 17, 2024

Last Updated

March 23, 2026

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)