Journal of neurotrauma
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Journal of neurotrauma · Sep 2015
Randomized Controlled Trial Multicenter Study Comparative StudyEarly surgery versus initial conservative treatment in patients with traumatic intracerebral haemorrhage [STITCH(Trauma)]: the first randomised trial.
Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. ⋯ The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.