Status:
WITHDRAWN
Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension
Lead Sponsor:
Fondation Lenval
Conditions:
Hypertension Intracranial
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions ...
Detailed Description
Severe Traumatic Brain Injury (STBI) constitutes the foremost cause of death and severe disability in the pediatric population. The severity of cranial trauma is evaluated by the Glasgow score. STBI c...
Eligibility Criteria
Inclusion
- Less than 18 years of age
- Severe traumatic brain injury (initial Glasgow coma scale \< 9)
- Accidental trauma
- Refractory intracranial hypertension: ICP \> 20 mmHg over 30 minutes for children more than one year of age and ICP \> 15 mmHg over 30 minutes for children of less than one year of age.
- The patient must receive optimal medical management
- Affiliation with a social security scheme
- Signed informed consent is to be provided by the two holders of parental authority
Exclusion
- Inflicted cranial trauma (e.g. shaken baby syndrome)
- Patients having an initial surgery for removal of an intracranial hemorrhagic collection of blood (e.g. a subdural hematoma, extradural hematoma, and intraparenchymal hematoma) for which the flap was not replaced.
- Pregnant patient
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03766087
Start Date
November 1 2019
End Date
June 1 2025
Last Update
May 19 2022
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France