Abstract
Background: To investigate the effects of decompressive craniectomy (DC) combined with hypothermia treatment on mortality and neurological outcomes in patients with large hemispheric infarction (LHI).Methods: Patients within 48 hours of symptom onset were randomized to the following three groups: the DC group, the DC plus head surface cooling (DCSC) group and the DC plus endovascular hypothermia (DCEH) group. Patients in the DC group were given standard medical treatment with a normothermic target temperature. Patients in the DCSC group received standard medical treatment plus 24-hour ice cap on the head for 7 days. Patients in the DCEH group were given standard medical treatment plus endovascular hypothermia with a target temperature of 34°C. The primary end-points were mortality and modified Rankin Scale (mRS) score at 6 months.Results: There were 9 patients in the DC group, 14 patients in the DCSC group and 11 patients in the DCEH group. The mortality rates of the DC, DCSC and DCEH groups at the time of discharge were 22.2% (2/9), 0% (0/14) and 9.1% (1/11), respectively. At 6 months, the mortality rates in the DC, DCSC and DCEH groups increased to 44.4% (4/9), 21.4% (3/14) and 45.5% (5/11), respectively (P=0.367). The most common cause of death after discharge was pneumonia (8 cases). 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, still without significant difference (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.Clinical 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.