Decompressive craniectomy for mass effect in severe head injury
Recruiting
- Conditions
- Severe traumatic brain injury with mass lesionsInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN20139421
- Lead Sponsor
- West China Hospital of Sichuan University (P. R. China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 336
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Favorable outcome at 12 months after randomization, measured by Extended Glasgow outcome scale (5–8)
- Secondary Outcome Measures
Name Time Method 1. Quality of life (EQ-5D) at 6 and 12 months after randomization<br>2. Mortality at 6 months and 12 months after randomization<br>3. Incidence of re-operation with salvage DC in craniotomy patients of therapeutic DC group at one month after randomization<br>4. ICP and CPP control during 1 week after randomization (intraoperative and postoperative)<br>5. Complications at 1 month, 6 months and 12 months