Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

Abstract

BackgroundIntracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH.Methods/DesignThe UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial.Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise.Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury.Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients.Trial registrationCurrent Controlled Trials ISRCTN19321911

Isolated unilateral IIIrd nerve palsy as the only sign of chronic subdural haematoma

“…This becomes even more important when we realize that surgery is very effective in patients of SDH and that the results are far better with an early surgical intervention rather than if it is delayed. 11 Finally we recommend that patients with ocular motor nerve palsy should always be carefully examined in close collaboration with other specialists, especially where sophisticated, complementary investigations are not available.…”

The Role of Surgical Intervention in Traumatic Brain Injury

“…Unfortunately, the only trial investigating the role of early surgery versus initial conservative treatment to anticipate and prevent secondary damage in traumatic ICH was halted early. 43,44 Although the evidence is limited due to the low sample size resulting from premature termination, it appears that the STITCH(Trauma) Trial observed reduced mortality with early surgery. 44 However, it is important to note that patients in this trial were mostly recruited in resource-limited settings where ICP monitoring was not usually available.…”

What’s new in the surgical management of traumatic brain injury?

“…temporal lobe or posterior fossa) often require surgical evacuation, especially if accompanied by radiological or clinical evidence of brainstem compression. The results of the STITCH (Trauma) trial are also expected to shed some light on the issue of surgical management of parenchymal mass lesions [8].…”