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@article{1309109, author = {Mendelow, David A. and Gregson, Barbara A. and Rowan, Elise N. and Francis, Richard and McColl, Elaine and McNamee, Paul and Chambers, Iain and Unterberg, Andreas and Boyers, Dwayne and Mitchell, Patrick M. and Smrčka, Martin and Hanoun, George}, article_location = {New Rochelle}, article_number = {17}, doi = {http://dx.doi.org/10.1089/neu.2014.3644}, keywords = {craniotomy; intracerebral hemorrhage; randomized; controlled trial; traumatic brain injury}, language = {eng}, issn = {0897-7151}, journal = {Journal of Neurotrauma}, title = {Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial}, url = {http://dx.doi.org/10.1089/neu.2014.3644}, volume = {32}, year = {2015} }
TY - JOUR ID - 1309109 AU - Mendelow, David A. - Gregson, Barbara A. - Rowan, Elise N. - Francis, Richard - McColl, Elaine - McNamee, Paul - Chambers, Iain - Unterberg, Andreas - Boyers, Dwayne - Mitchell, Patrick M. - Smrčka, Martin - Hanoun, George PY - 2015 TI - Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial JF - Journal of Neurotrauma VL - 32 IS - 17 SP - 1312-1323 EP - 1312-1323 PB - MARY ANN LIEBERT SN - 08977151 KW - craniotomy KW - intracerebral hemorrhage KW - randomized KW - controlled trial KW - traumatic brain injury UR - http://dx.doi.org/10.1089/neu.2014.3644 L2 - http://dx.doi.org/10.1089/neu.2014.3644 N2 - 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 10mL 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. ER -
MENDELOW, David A., Barbara A. GREGSON, Elise N. ROWAN, Richard FRANCIS, Elaine MCCOLL, Paul MCNAMEE, Iain CHAMBERS, Andreas UNTERBERG, Dwayne BOYERS a Patrick M. MITCHELL. Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial. \textit{Journal of Neurotrauma}. New Rochelle: MARY ANN LIEBERT, 2015, roč.~32, č.~17, s.~1312-1323. ISSN~0897-7151. Dostupné z: https://dx.doi.org/10.1089/neu.2014.3644.
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