Health Condition 1: S061- Traumatic cerebral edema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Closed head injury patients in whom brain swelling is indicative of raised intracranial pressure that is no longer controlled by medical management
Exclusion criteria
Exclusion criteria: Unsurvivable injury Comoborbidities that prevent surgical treatment Previous history of decompressive craniectomy (DC) or cranioplasty where further DC or hinge craniotomy cannot be done.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extended Glasgow Outcome Scale (GOSE)Timepoint: 12 months from injury | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in intracranial pressureTimepoint: 24 hours after the intervention (surgery) [if an ICP monitoring was done];Extended Glasgow Outcome Scale (GOSE)Timepoint: One, three, and six months;Wound complicationsTimepoint: 14 days of intervention;Postoperative hydrocephalusTimepoint: 12 months after injury;Timing of cranioplasty (in the DC group)Timepoint: 12 months after injury;Method of storage of the bone flap in the DC groupTimepoint: 12 months of injury;Duration of hospitalisationTimepoint: 12 months of injury | — |
Countries
Brazil, India, Pakistan
Contacts
National Institute of Mental Health and Neurosciences (NIMHANS)