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Not yet recruitingNCT06847516Updated Feb 26, 2025

Predictors of Clinical and Neurological Outcome in Traumatic Posterior Fossa Epidural Hematoma

An observational study in Posterior Fossa Epidural Hematoma, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
94
Sex
All
01

Study summary

The posterior fossa is a small space in the skull containing the brainstem and cerebellum. If a mass such as a hemorrhage grows in this region, particularly the brainstem and 4th ventricle, it can block the normal flow of cerebral spinal fluid leading to hydrocephalus, increased intracranial pressure.Posterior fossa extradural hematoma (PFEDH) is a rare neurosurgical entity, resulting in rapid clinical deterioration. The accumulation of blood in a potentially small space between the dura and occipital bone cause compression of the brain stem.These hematomas constitute almost 4% to 12.9% of all extradural hematoma cases.

The extradural hematomas of the posterior fossa may be categorized as acute or delayed defined with respect to the brainstem compression appearing within or after 24 hours of injury, respectively. Acute PFEDH is characterized by medullar failure, occipital trauma associated with severe pain in the nuchal area, altered consciousness followed by rapid brainstem compression, respiratory depression, and subsequent death if not treated timely and appropriately.Whereas, headache, neck pain, dysfunction of lower cranial nerve in response to PF lesions and cerebellar signs. The clinical features of PFEDH are nonspecific; it may include occipital headache, vomiting due to raised intracranial pressure, and decreased consciousness level leading to death. The skull fractures must be considered as a predisposing factor for the development of delayed extradural hematomas.

The aim of this study is :

  • To evaluate the outcome of patients with traumatic post fossa Epidural hematoma
  • list the predictors of outcome for patients with post fossa Epidural hematoma
02

Conditions studied

  • Posterior Fossa Epidural Hematoma

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with Traumatic Posterior fossa epidural hematoma

Inclusion criteria

  • Any age
  • Traumatic Posterior fossa epidural hematoma

Exclusion criteria

Exclusion Criteria:

  • Spontaneous type of epidural heamatoma
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
94 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

    patients admitted to Neurosurgery department withTraumatic Posterior fossa epidural hematoma

05

What researchers measure

Primary outcomes

  1. The postoperative GOS score

    he Glasgow outcome scale (GOS). GOS score four and five were considered good recovery outcomes, GOS 2 and 3 indicated poor outcomes, and OS one indicated mortality.

    Time frame: 30 day

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06847516
Lead sponsor
Assiut University
Responsible party
Helal sayed ali (residant doctor, Assiut University) — Principal investigator
First posted
Feb 26, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Feb 26, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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