Surgical Decision Making in Brain Hemorrhage

Abstract

Background and Purpose- The STICH (Surgical Trial in Lobar Intracerebral Haemorrhage) I and II trials randomized patients with spontaneous intracerebral hemorrhage (ICH) to early surgery or initial conservative treatment. Both were nonsignificant; possibly because surgery has minimal effect on recovery, or because surgery benefits some and harms others. We introduce a new nonparametric method of analysis. The method is then applied to data from a third trial, STITCH(Trauma) (Surgical Trial in Traumatic Intracerebral Haemorrhage), which addressed a similar surgical question in head-injured patients. Methods- Data from 1541 patients from the STICH trials were analyzed using (1) standard meta-analysis of prognosis-based dichotomized outcome and prespecified standard subgroups of Glasgow Coma Scale (GCS): 3-8, 9-12, and 13-15; (2) new nonparametric regression of ranked Extended Glasgow Outcome Scale against ranked GCS and ranked volume; and (3) analysis (1) repeated using categories identified by analysis (2). Results- Standard meta-analysis showed more favorable outcomes, although nonsignificant, with surgery if presenting GCS was 9-12 (spontaneous ICH odds ratio, 0.70 [95% CI, 0.48-1.03; P=0.07]; traumatic odds ratio, 0.48 [95% CI, 0.18-1.26; P=0.14]). Ranked analysis showed a similar pattern of results for both spontaneous and traumatic ICH. Surgery was harmful for small lesions with increasing benefit for larger volumes. With GCS, surgery had little effect at either ends of the spectrum but suggested a beneficial effect in the range 10 to 13 (identified graphically). Repeating the meta-analysis with this categorization showed significant benefit for surgery (spontaneous odds ratio, 0.71 [95% CI, 0.51-1.00; P=0.05]; traumatic odds ratio, 0.16 [95% CI, 0.05-0.51; P=0.002]). Conclusions- The nonsignificant results observed in the STICH trials are because of mixing patients who benefit from surgery with those who are harmed. Patients with a GCS 10-13 or a large ICH are likely to benefit from surgery. Our analysis showed a similar effect on traumatic ICH/contusion data and promises to be a valuable tool. Clinical Trial Registration- URL: http://www.isrctn.com/ . Unique identifiers: ISRCTN19976990 (STITCH), ISRCTN22153967 (STICH II), and ISRCTN19321911 (STITCH[Trauma]).

Keywords: Glasgow Outcome Scale; cerebral hemorrhage; conservative treatment; decision making; surgery.

Figures

Figure 1.

Forest plots. A, All spontaneous intracerebral hemorrhage (ICH) patients. B, All traumatic ICH patients. C, Spontaneous ICH by Scale (GCS) with standard grouping (<9, 9–12, and 13–15). D, Traumatic ICH by GCS with standard grouping (<9, 9–12, and 13–15).

Figure 2.

In these figures in all cases the total population, including both early surgery and initial conservative patients are ranked according to the parameters of Glasgow Coma Scale (GCS) at presentation and clot volume for the x axis and Extended Glasgow Outcome Scale (GOSE) for the y axis. A case’s ranking is equal to the number of cases below or equal to that case in the parameter involved so that, for example, in the combined STICH I and II trials (Surgical Trial in Lobar Intracerebral Haemorrhage), there were 485 patients with a GOSE of 1 (died) and they were all given a ranking of 485 shown by the horizontal line. Only 2 patients had a GOSE of 2 (vegetative) so the grid line for this outcome cannot be resolved from that for GOSE 1. The x axis is simply all patients ranked. Equal spacing on the axes equals equal numbers of patients. On the y axis nonparametric regression values are plotted using Matlab 8.5.0.197613 (R2015a) malowess with robustness and spans given below. Spans were determined by inspection. The area between the lines was used as the statistic for P value calculations. A, Data combined from the STICH and STICH II trials plotting ranked presenting GCS against a nonparametric regression of ranked GOSE. Span was 0.4, P=0.4. B, Data from the STITCH(Trauma) trial (Surgical Trial in Traumatic Intracerebral Haemorrhage) plotting ranked presenting GCS against nonparametric regression of ranked extended GOS. Span is 0.4, P=0.012. C, Data combined from the STICH and STICH II trials (Surgical Trial in Lobar Intracerebral Haemorrhage), plotting ranked presenting clot volume against nonparametric regression of ranked GOSE. Span was 0.55, P=0.042. D, Data from the STITCH(Trauma) trial (Surgical Trial in Traumatic Intracerebral Haemorrhage) plotting ranked presenting contusion volume against nonparametric regression of ranked GOS. Span is 0.4, P=0.013.

Figure 3.

Forest plots using new categorization of Glasgow Coma Scale (GCS; ≤9, 10–13, and 14–15). A, Spontaneous intracerebral hemorrhage (ICH) studies. B, Traumatic ICH study.