The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre randomised trial to evaluate the effect of early decompressive
      craniectomy on neurological function in patients with severe traumatic brain injury.

      The primary outcome is neurological function measured at 6 months post injury using the
      Glasgow Outcome Score. Neurological function is qualified as proportion of favourable
      outcomes (Glasgow Outcome Score Extended [GOSE] grades 5-8).
    

Detailed description: 
      Comparison After meeting the entry criteria, and the patient will be randomised to either
      early DC surgery (see below) or best current conventional management. Those randomised to
      surgery will have the operation done within 6 hours of randomisation. They will then return
      to the ICU and be managed thereafter in the same way as the conventional arm. Patients in the
      conventional arm will have all the usual therapies for increasing ICP optimised again. They
      then may have cooling to 35.0C or thiopentone bolus or thiopentone coma. These options are at
      the clinicians discretion. Late DC surgery in the control patients is discouraged however it
      may be done at the neurosurgeons discretion. These patients will be included in the intention
      to treat analysis.

      Surgical Technique The technique described by Polin will be used. The operation will comprise
      bi-frontal decompressive craniectomies with a single fronto-temporal bone flap extending
      across the midline. The temporalis muscles will be reflected inferiorly. Burr holes are
      located either side of the sagittal sinus at the posterior extent and bilaterally at the
      keyhole and at the root of the zygoma. This will create a large bifrontal craniectomy defect
      extending posteriorly to the coronal sutures. Bilateral large sub-temporal decompressions
      will be performed down to the skull base. The final bone cut is made along the supra-orbital
      ridges with an attempt to preserve the frontal sinus. Burr holes will be placed either side
      of the sagittal sinus inferiorly and the bone will be lifted out.

      The dura will be opened in one of two alternative ways:

        1. The dura is opened with a cruciate incision bilaterally. OR

        2. A large L shaped incision with the lower corner of the L facing laterally. The advantage
           to this method is that the cerebral veins are not disturbed medially by this incision.

      The dural opening should be covered with a dural or facial patch, so that the brain does not
      adhere to the scalp. Water tight dural closure is not necessarily aimed for. For patients
      receiving EVD monitoring, an ICP monitor with ventricular catheter (± optional PO2 and
      temperature monitor) may be placed prior to closure. Some patients will have been randomised
      to parenchymal catheter only. These patients will not have an EVD inserted.

      The bone flap is replaced once bone swelling has resolved and the patient has improved and
      left the intensive care unit (6-12 weeks). The bone flap is stored at minus 20o-70oC until
      reinsertion or it may be implanted in the subcutaneous tissue of the abdominal wall as an
      alternative.
    

Intervention name(s): Early decompressive craniectomy
Intervention type(s): Procedure
Intervention description(s): Large bifrontotemporal decompressive craniectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe diffuse TBI refractory intracranial hypertension.