Decompressive craniectomy combined with mild hypothermia in patients with large hemispheric infarction: a randomized controlled trial

Abstract

Abstract Background The effect of hypothermia on large hemispheric infarction (LHI) remains controversial. Our study aimed to explore the therapeutic outcomes of decompressive craniectomy (DC) combined with hypothermia on LHI. Methods Patients were randomly divided into three groups: the DC group, the DC plus head surface cooling (DCSC) group and the DC plus endovascular hypothermia (DCEH) group. The DC group was maintained normothermia. The DCSC group received 24-h ice cap on the head for 7 days. While the DCEH group were given endovascular hypothermia (34 °C). Mortality and modified Rankin Scale (mRS) score at 6 months were evaluated. Results Thirty-four patients were included in the study. Mortality of the DC, DCSC and DCEH groups at discharge were 22.2% (2/9), 0% (0/14) and 9.1% (1/11), respectively. However, it increased to 44.4% (4/9), 21.4% (3/14) and 45.5% (5/11) at 6 months, respectively (p = 0.367). Pneumonia (8 cases) was the leading cause of death after discharge. Twelve cases (35.3%) achieved good neurological outcome (mRS 0–3) at 6 months. The proportions of good neurological outcome in the DC, DCSC and DCEH groups were 22.2% (2/9 cases), 42.9% (6/14 cases) and 36.4% (4/11), respectively. The DCSC group seemed to have higher proportion of good outcomes, but there was no significant difference between groups (p = 0.598). Among survivors, endovascular hypothermia had a higher proportion of good outcome (DC group, 2/5 cases, 40.0%; DCSC group, 6/11 cases, 54.5%; DCEH group, 4/6 cases, 66.7%; p = 0.696). The incidence of complications in the DCEH group was higher than those of the DC and DCSC groups (18.9%, 12.0%, and 12.1%, respectively; p = 0.025). Conclusions There is still no evidence to confirm that hypothermia further reduces long-term mortality and improves neurological outcomes in LHI patients with DC. However, there is a trend to benefit survivors from hypothermia. A local cooling method may be a better option for DC patients, which has little impact on systematic complications. Trial registration Decompressive Hemicraniectomy Combined Hypothermia in Malignant Middle Cerebral Artery Infarct, ChiCTR-TRC-12002698. Registered 11 Oct 2012- Retrospectively registered, URL: http://www.chictr.org.cn/showproj.aspx?proj=6854.