Surgical management of acute epidural hematomas.
M Ross Bullock, Randall Chesnut, Jamshid Ghajar...
https://pubmed.ncbi.nlm.nih.gov/16710967Actively Recruiting
Age: 18Years - 65Years
All Genders
ID04229966
A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
Led by RenJi Hospital · Updated on 2026-01-14
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
C
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to investigate the current surgical treatments and outcomes for acute epidural hematoma (AEDH) in patients with traumatic brain injury (TBI) in China. The study focuses on understanding how different surgical approaches affect patient prognosis, especially given that AEDH can be life-threatening due to increased pressure on the brain. The research also explores optimizing therapy choices based on real-world data from multiple centers. Participants receive surgical treatment for AEDH as determined necessary by their neurosurgeon, with the study observing these treatments without assigning specific interventions. The study is prospective and observational, meaning it follows patients over time after their surgery to record outcomes. No experimental drugs or procedures are given; instead, the study collects data on surgical methods used and their results. Throughout the study, participants will be monitored for up to six months after their injury. Researchers will evaluate recovery using tools like the extended Glasgow Outcome Scale (GOSE), record any additional surgeries, assess complications such as cerebral infarction, and measure quality of life and cognitive function. Hospital and ICU stay lengths, economic factors, and serious adverse events will also be tracked to provide a comprehensive view of recovery after AEDH surgery.
CONDITIONS
Brief Title
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Clear medical history of traumatic brain injury
- Injury occurred within 12 hours before enrollment
- Supratentorial unilateral acute epidural hematoma shown on first head CT scan
- Neurosurgeon recommends surgical evacuation of the hematoma
- Informed consent given for surgery and study participation
You will not qualify if you...
- Previous intracranial surgery before the trauma
- Glasgow Coma Scale score of 3 with bilateral fixed and dilated pupils, bleeding disorders, or unsurvivable injury
- Presence of other major intracranial hematomas or large infarctions as main cause for surgery
- Injury to the oculomotor nerve
- Severe pre-existing disability or serious co-morbidities that affect recovery
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to several days depending on clinical need
Participants undergo surgical evacuation of the acute epidural hematoma as recommended by their neurosurgeon, followed by immediate post-operative care.
Post-operative Follow-up
Duration - Up to 6 months post-injury
Participants are observed and assessed for clinical outcomes and potential complications such as cerebral infarction, additional surgeries, and recovery progress.
Multiple visits over 6 months for assessments including clinical evaluations and quality of life measurements
Trial Site Locations
Total: 1 location
1
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Actively Recruiting
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Research Team
J
Junfeng Feng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Outcome following evacuation of acute subdural haematomas: a comparison of craniotomy with decompressive craniectomy.
Lucia M Li, Angelos G Kolias, Mathew R Guilfoyle...
https://pubmed.ncbi.nlm.nih.gov/22752713Novel Clinical Scale for Evaluating Pre-Operative Risk of Cerebral Herniation from Traumatic Epidural Hematoma.
Hong Lin, Wen-Hao Wang, Lian-Shui Hu...
https://pubmed.ncbi.nlm.nih.gov/25393339Risk factors for post-traumatic massive cerebral infarction secondary to space-occupying epidural hematoma.
Wen-hao Wang, Lian-shui Hu, Hong Lin...
https://pubmed.ncbi.nlm.nih.gov/24773559Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH).
Chun Yang, Jiyuan Hui, Li Xie...
https://pubmed.ncbi.nlm.nih.gov/35264341