Clot removAl with or without decompRessive craniectomy under ICP monitoring for supratentorial IntraCerebral Hemorrhage (CARICH): a randomized controlled trial

Background:Decompressive craniectomy (DC), a surgery to remove part of the skull and open the dura mater, maybe an effective treatment for controlling intracranial hypertension. It remains great interest to elucidate whether DC is beneficial to intracerebral hemorrhage (ICH) patients who warrant clot removal (CR) to prevent intracranial hypertension.Methods:The trial was a prospective, pragmatic, controlled trial involving adult patients with ICH who were undergoing removal of hematoma. ICH patients were randomly assigned at a 1:1 ratioto undergo CR with or without DC under the monitoring of intracranial pressure. The primary outcome was the proportion of unfavorable functional outcome (modified Rankin Scale 3-6) at 3 months. Secondary outcomes included the mortality at 3 months and the occurrence of reoperation.Results:A total of 102 patients were assigned to the CR with DC group and 102 to the CR group. Median hematoma volume was 54.0 ml (range 30-80 ml) and median preoperative Glasgow Coma Scale was 10 (range 5-15). At 3 months, 94 patients (92.2%) in CR with DC group and 83 patients (81.4%) in the CR group had unfavorable functional outcome (P=0.023). Fourteen patients (13.7%) in the CR with DC group died versus five patients (4.9%) in the CR group (P=0.030). The number of patients with reoperation was similar between the CR with DC group and CR group (5.9 vs. 3.9%; P=0.517). Postoperative intracranial pressure values were not significantly different between two groups and the mean values were less than 20 mmHg.Conclusions:CR without DC decreased the rate of modified Rankin Scale score of 3-6 and mortality in patients with ICH, compared with CR with DC.