Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorRenJi Hospital
About this trial
This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clear medical history of traumatic brain injury;
within 12 hours after injury;
Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
Disqualifiers
Previous intracranial surgery prior to trauma;
Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable;
CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
Patients who had injury of the oculomotor nerve;
Trial population
The population who were diagnosed with acute epidural hematoma and necessary for undergoing evacuation of an acute epidural hematoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
GOSE (extended Glasgow Outcome Scale) scores
The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the Extended Glasgow Outcome Scale (GOS-E), "Extended Glasgow Outcome Scale" is the unabbreviated scale title. The minimum value of scale is score 1, and maximum value is scored 8, higher scores mean a better outcome and lower scores mean worse outcome. Specific scored as follows: 1. death; 2. persistent vegetative state; 3. lower severe disability; 4. upper severe disability; (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living); 5. lower moderate disability; 6. upper moderate disability; (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment); 7. lower good recovery; 8. upper good recovery (stratum 7 and 8 were considered as good recovery).
Time frame
at 6 months post-injurySecondary outcomes
1
incidence of post-operative cerebral infarction
The incidence of traumatic AEDH post-operative cerebral infarction within 6 months post-injury, which is primarily diagnosed by independent radiologists with CT or MRI examination.
Time frame
within 6 months post-injury2
incidence of additional craniocerebral surgery
The incidence of additional craniocerebral surgery within 6 months post-injury, related to clinical deterioration after initial surgical treatment of AEDH.
Time frame
within 6 months post-injury3
length of stay in ICU and hospital
The duration of hospitalization after initial surgery within 6 months post-injury, including ICU and hospital stays.
Time frame
within 6 months post-injury4
detailed economic evaluation
Total medical expense related to treatment of AEDH, including the costs of operations, hospitalization and rehabilitation within 6 months post-injury.
Time frame
within 6 months post-injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
Collaborator
Shenzhen Second People's Hospital
Collaborator
Source ClinicalTrials.gov