Severe traumatic brain injury with mass lesions Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Once the eligible patient signs consent and confirms randomization, the interventions commence. Participants will be randomly allocated to either prophylactic DC group or therapeutic DC group. During
Sponsors
West China Hospital of Sichuan University (P. R. China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 15 and 65 years old 2. Glasgow Coma Scale (GCS) = 8 3. Marshall Classification VI, presence of high- or mix-density lesion = 25 ml (contusion, intraparenchymal and subdural hematoma) 4. Neurological status progressive deterioration within 24 h after injury (GCS motor score fall by 2 points or blunt pupillary response)
Exclusion criteria
Exclusion criteria: 1. Bilateral mydriasis of critically endangered status 2. Cerebellum contusion 3. Penetrating brain injury 4. Serious extracranial injury with unstable vital signs 5. Beyond 24 h after injury 6. Known cognitive or neurological impairment 7. Breastfeeding or pregnancy 8. Definite surgical contraindications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Favorable outcome at 12 months after randomization, measured by Extended Glasgow outcome scale (5–8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (EQ-5D) at 6 and 12 months after randomization 2. Mortality at 6 months and 12 months after randomization 3. Incidence of re-operation with salvage DC in craniotomy patients of therapeutic DC group at one month after randomization 4. ICP and CPP control during 1 week after randomization (intraoperative and postoperative) 5. Complications at 1 month, 6 months and 12 months | — |
Countries
China
Outcome results
None listed