- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06847516
Predictors of Clinical and Neurological Outcome in Traumatic Posterior Fossa Epidural Hematoma
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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any age
- Traumatic Posterior fossa epidural hematoma
Exclusion Criteria:
- Spontaneous type of epidural heamatoma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Group A
patients admitted to Neurosurgery department withTraumatic Posterior fossa epidural hematoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The postoperative GOS score
Time Frame: 30 day
|
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.
|
30 day
|
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
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
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Epidural, Cranial
- Hematoma, Epidural, Spinal
Other Study ID Numbers
- clinical +NeurologicalPFEH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posterior Fossa Epidural Hematoma
-
University of California, San FranciscoPediatric Neuro-Oncology Consortium; The Lilabean Foundation, Inc.RecruitingPosterior Fossa Ependymal TumorUnited States
-
Hospices Civils de LyonCompletedPosterior Brain Fossa Tumors in ChildrenFrance
-
Assiut UniversityNot yet recruitingPediatric Tumor | Midline Posterior Fossa Tumors
-
Peking University Third HospitalNot yet recruitingSpinal Epidural Hematoma
-
University of Health Sciences LahoreNot yet recruitingPosterior Fossa Lesion
-
Baxter Healthcare CorporationCompletedDura Defects | Pathological Processes in the Posterior FossaUnited States, Canada
-
Peking University Third HospitalCompletedSymptomatic Epidural Hematoma After Cervical Spine Surgery
-
Peking University Third HospitalCompletedThoracic Surgery | Spinal Epidural HematomaChina
-
Changhai HospitalThe First People's Hospital of ChangzhouRecruitingTraumatic Brain Injury | EpiDural HematomaChina
-
The Fourth Affiliated Hospital of Zhejiang University...CompletedDrain Tube Influence the Postoperative Epidural HaematomaChina