Traumatic Brain InjuryNCT07822724
Outcomes of Traumatic Intracranial Hemorrhage in the Elderly
An observational study of Traumatic Brain Injury and Subdural Hematoma, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subdural Hematoma, Epidural Hematoma
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: The study population consists of geriatric patients (aged 65 years or older) admitted to the Neurosurgery Department at Assiut University Trauma Hospital. These patients present with a history of blunt or traumatic head injury and have CT-confirmed intracranial hemorrhage. The study focuses specifically on patients who are managed conservatively.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury, Subdural Hematoma, Epidural Hematoma
- Keywords
- Traumatic Intracranial Hemorrhage, Geriatric, Elderly, Head Trauma, Traumatic Brain Injury, Prognostic Factors
- Medical subject headings
- Brain Injuries, Traumatic, Hematoma, Subdural, Hematoma, Epidural, Spinal, Intracranial Hemorrhage, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome assessed by the Glasgow Outcome Scale-Extended (GOSE)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mokhtar Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822724
- Sponsor's protocol ID
- Traumatic ICH in the Elderly
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Intracranial Hemorrhage in the Elderly: Prognostic Factors and Outcomes
- ClinicalTrials.gov ID
- NCT07822724
- Acronym / sponsor ID
- Traumatic ICH in the Elderly
- Conditions
- Traumatic Brain Injury, Subdural Hematoma, Epidural Hematoma
- Keywords
- Traumatic Intracranial Hemorrhage, Geriatric, Elderly, Head Trauma, Traumatic Brain Injury, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- The study population consists of geriatric patients (aged 65 years or older) admitted to the Neurosurgery Department at Assiut University Trauma Hospital. These patients present with a history of blunt or traumatic head injury and have CT-confirmed intracranial hemorrhage. The study focuses specifically on patients who are managed conservatively.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome assessed by the Glasgow Outcome Scale-Extended (GOSE)
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Subdural Hematoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome assessed by the Glasgow Outcome Scale-Extended (GOSE) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.