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Lookup NU author(s): Emeritus Professor David Mendelow, Dr Barbara Gregson, Dr Elise Rowan, Dr Richard Francis, Emerita Professor Elaine McCollORCiD, Patrick Mitchell
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
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.
Author(s): Mendelow AD, Gregson BA, Rowan EN, Francis R, McColl E, McNamee P, Chambers IR, Unterberg A, Boyers D, Mitchell PM, STITCH Trauma Investigators
Publication type: Article
Publication status: Published
Journal: Journal of Neurotrauma
Year: 2015
Volume: 32
Issue: 17
Pages: 1312-1323
Print publication date: 17/08/2015
Online publication date: 21/05/2015
Acceptance date: 01/01/1900
Date deposited: 20/04/2016
ISSN (print): 0897-7151
ISSN (electronic): 1557-9042
Publisher: Mary Ann Liebert, Inc. Publishers
URL: http://dx.doi.org/10.1089/neu.2014.3644.
DOI: 10.1089/neu.2014.3644
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