Investigating the optimal time for surgical repair of the skull by cranioplasty following a traumatic brain injury or stroke.
Not Applicable
Recruiting
- Conditions
- Traumatic brain injury or middle cerebral infarct.Nervous System Diseases
- Registration Number
- ISRCTN14996072
- Lead Sponsor
- niversity of Cambridge and Cambridge University Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Aged 16 or over
2. Require a cranioplasty after a supratentorial decompressive craniectomy for TBI or MCA infarct.
Exclusion Criteria
1. Cranioplasty cannot be undertaken within 3 months from the craniectomy date.
2. Craniectomy is undertaken for a condition other than TBI or ischaemic stroke.
3. If consent cannot be gained by either patient or next of kin or family member.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient status will be measured using the extended Glasgow Outcome Scale at 6 months.
- Secondary Outcome Measures
Name Time Method <br> To be measured at baseline and 2 months after craniectomy, with additional follow up at 6, 12 and 18 months:<br> 1. Long-term clinical effectiveness of early vs late cranioplasty will be measured at the 18 months follow-up period.<br> 2. Quality of life will be measured using the EQ-5D-5L and QOLIBRI.<br> 3. Behavioural and psychological symptoms will be measured using the NPI-Q.<br> 4. Surgical complications will be measured using patient reporting and medical notes.<br> 5. Adverse events will be measured using patient reporting and medical notes.<br> 6. Health economics evaluation will be measured using the EQ-5D-5L at 18 months.<br>