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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-07-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

NCT02326571

Cerebral Hemorrhage

COMPLETED

Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage

NCT06429553

Spontaneous Cerebral Hemorrhage

RECRUITING NA

International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage

NCT00928915

Intracranial Hemorrhages

COMPLETED PHASE4

Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

NCT00827892

Intracerebral Hemorrhage

COMPLETED PHASE2

rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets

NCT00222625

Intracerebral Hemorrhage

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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