Investigating the optimal time for surgical repair of the skull by cranioplasty following a traumatic brain injury or stroke.

Comparing the functional outcome of adult patients who have undergone a supratentorial craniectomy due to traumatic brain injury or a large ischaemic stroke after early vs late cranioplasty: a pilot randomised controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14996072

Enrollment

Registered

2019-03-22

Start date

2019-03-04

Completion date

Unknown

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury or middle cerebral infarct. Nervous System Diseases

Interventions

The REEL trial is a pilot, prospective, parallel group randomised trial with 1:1 allocation ratio to early v late cranioplasty. The aim is to understand better whether a strategy of early cranioplasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 16 or over 2. Require a cranioplasty after a supratentorial decompressive craniectomy for TBI or MCA infarct.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Patient status will be measured using the extended Glasgow Outcome Scale at 6 months.	—

Secondary

Measure	Time frame
To be measured at baseline and 2 months after craniectomy, with additional follow up at 6, 12 and 18 months: 1. Long-term clinical effectiveness of early vs late cranioplasty will be measured at the 18 months follow-up period. 2. Quality of life will be measured using the EQ-5D-5L and QOLIBRI. 3. Behavioural and psychological symptoms will be measured using the NPI-Q. 4. Surgical complications will be measured using patient reporting and medical notes. 5. Adverse events will be measured using patient reporting and medical notes. 6. Health economics evaluation will be measured using the EQ-5D-5L at 18 months.	—

Measure

Time frame

To be measured at baseline and 2 months after craniectomy, with additional follow up at 6, 12 and 18 months: 1. Long-term clinical effectiveness of early vs late cranioplasty will be measured at the 18 months follow-up period. 2. Quality of life will be measured using the EQ-5D-5L and QOLIBRI. 3. Behavioural and psychological symptoms will be measured using the NPI-Q. 4. Surgical complications will be measured using patient reporting and medical notes. 5. Adverse events will be measured using patient reporting and medical notes. 6. Health economics evaluation will be measured using the EQ-5D-5L at 18 months.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026