REEL Cranioplasty Trial

• Research type

  Research Study

• Full title

  Randomised Evaluation of Early vs Late Cranioplasty REEL-Cranioplasty trial

• IRAS ID

  252606

• Contact name

  Harry William James Mee

• Contact email

  harrymee@nhs.net

• Sponsor organisation

  Cambridge University and Cambridge NHS Trust

• ISRCTN Number

  ISRCTN14996072

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  In the first few days after a serious traumatic brain injury (TBI) or a large middle cerebral artery infarct (MCA) (a type of stroke) patients can develop swelling in the brain which can lead to brain damage or even death. Craniectomy is a surgical procedure in which part of the skull is removed to relieve brain swelling. A number of high-quality studies, including one from the UK published in 2016, have shown that a craniectomy can be helpful in the management of patients with dangerous levels of swelling. Patients who survive undergo an operation, known as cranioplasty, in order to have their skull reconstructed. Traditionally, cranioplasties were undertaken around 10-12 months after the craniectomy, as it was thought that early cranioplasty can increase the risk of infection. However, recent systematic reviews have challenged this view. In addition, a number of small studies have suggested that early cranioplasty may enhance recovery.
  We are proposing a high-quality study (randomised trial) that will aim to answer whether early cranioplasty (within 3 months from craniectomy) is more beneficial for patients than late cranioplasty (more than 6 months from craniectomy).
  All patients, who are stable after a craniectomy, will be considered for the research project. Following consent, patients will be randomly placed into one of the two groups of the study: one group will have the cranioplasty within 3 months, while the other group will have it more than 6 months after the craniectomy. All patients will otherwise be managed as per usual local practice. Patients will be followed up for up to 18 months after the craniectomy, with the focus on activities of daily living, behavioural and psychological symptoms, quality of life, and complications. We will also undertake an economic analysis and an embedded qualitative study in order to fully understand the findings.

• REC name

  Wales REC 7

• REC reference

  18/WA/0425

• Date of REC Opinion

  22 Jan 2019

• REC opinion

  Further Information Favourable Opinion