Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial

Abstract

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. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, −4.4–25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). 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.

Acute Management of Traumatic Brain Injury

“…27,28 The STITCH (Trauma) trial, a Surgical Trial in Traumatic intraCerebral Hemorrhage, which compared 6 month outcomes in trauma patients with intraparenchymal hemorrhage randomized to early operative evacuation (<12 hours) to conservative management, was stopped early at 170 patients due to recruitment issues but showed a mortality benefit in patients who underwent early operative intervention. 29 …”

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

“…The results are not generalizable to patients with acute subdural hematoma or other pathology for which unilateral decompressive craniectomy is frequently performed. The recent Surgical Trial in Traumatic Intracerebral Haemorrhage (STITCH(TRAUMA)) 58 was prematurely halted by the funding agency because of slow recruitment. On analysis, a strong trend to benefit of early surgery of contusions in patients with a GCS of 9-12 was noted.…”

Delayed intraventricular hemorrhage in moderate-to-severe traumatic brain injury: prevalence, associated risk factors, and prognosis

“…The median GCS score on admission was 8 (interquartile range, [6][7][8][9][10][11][12]. The median lowest GCS score in the first 48 h was 7 (interquartile range, 4-10).…”

“…These include a statistically significant survival advantage (85 vs. 67 %) related with early surgery and best outcome of patients with an initial GCS between 9 and 12 in the early surgery group. Investigators recommend a larger trial for confirming this potentially beneficial effect of earlier surgery [11].…”