NCT07822724

Brief 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. 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.

Trial Health

65
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Traumatic Intracranial HemorrhageGeriatricElderlyHead TraumaTraumatic Brain InjuryPrognostic Factors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticHematoma, SubduralHematoma, Epidural, SpinalIntracranial Hemorrhage, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Neurosurgery

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 16, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 16, 2026

Record last verified: 2026-09