- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07822724
Outcomes of Traumatic Intracranial Hemorrhage in the Elderly
Traumatic Intracranial Hemorrhage in the Elderly: Prognostic Factors and Outcomes
This observational study aims to describe the clinical and radiological characteristics of older adults (aged 65 years and older) who experience traumatic bleeding in the brain, also known as traumatic intracranial hemorrhage. In older patients, even minor head injuries like a simple ground-level fall can lead to significant brain bleeding due to age-related changes, frailty, and the frequent use of blood-thinning medications.
The researchers will prospectively monitor geriatric patients admitted to the hospital with a traumatic brain bleed confirmed by a CT scan who are being treated conservatively (without surgery). During the hospital stay, the research team will collect data on the patients' pre-injury health status, current clinical condition, and specific findings on their brain scans.
The main goal of the study is to assess the patients' functional recovery and survival by the time they are discharged from the hospital. By observing these cases, the study seeks to identify which specific clinical signs and radiological factors help predict poor or favorable outcomes, ultimately aiming to improve the management and care of older adults with head trauma.
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 65 years or older.
- History of blunt or traumatic head injury.
- CT-confirmed intracranial hemorrhage.
- Conservatively managed patients.
- Availability of clinical and radiological data.
- Consecutive eligible patients during the defined study period.
Exclusion Criteria:
- Non-traumatic intracranial hemorrhage.
- Age less than 65 years.
- Incomplete medical records.
- Patients with major pre-existing intracranial pathology that prevents proper analysis.
- Penetrating brain injury.
- Surgically managed patients.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Geriatric Patients with Traumatic Intracranial Hemorrhage
This cohort consists of conservatively managed patients aged 65 years or older with a history of blunt or traumatic head injury and CT-confirmed intracranial hemorrhage.
Patients who are managed surgically or those with a penetrating brain injury are excluded from this cohort.
Because this is an observational study, no experimental interventions are administered to the participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional outcome assessed by the Glasgow Outcome Scale-Extended (GOSE)
Time Frame: Baseline
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Functional outcome will be evaluated using the Glasgow Outcome Scale-Extended (GOSE).
The GOSE scale ranges from 1 to 8, where higher scores indicate a better functional outcome.
The results are subsequently categorized to define an unfavorable outcome as a GOSE score of 1-4, and a favorable outcome as a GOSE score of 5-8.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Pathologic Processes
- Hemorrhage
- Trauma, Nervous System
- Intracranial Hemorrhages
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Hematoma
- Brain Injuries, Traumatic
- Hematoma, Subdural
- Craniocerebral Trauma
- Hematoma, Epidural, Spinal
- Intracranial Hemorrhage, Traumatic
Other Study ID Numbers
- Traumatic ICH in the Elderly
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