Decompressive craniectomy and expansive duraplasty with evacuation of hypertensive intracerebral hematoma, a randomized controlled trial.

Hypertensive intracerebral hemorrhage (ICH) has high morbidity and mortality rates. Decompressive craniectomy (DC) is generally used for the treatment of cases associated with refractory increased intracranial pressure (ICP). In this study, we investigated the beneficial effects of adding DC and expansive duraplasty (ED) to hematoma evacuation in patients who underwent surgery for large hypertensive ICH. A prospective randomized controlled clinical trial where 40 patients diagnosed having large hypertensive ICH was randomly allocated to either group A or B, each comprised 20 patients. Group A patients, the treatment group, were submitted to hematoma evacuation together with DC and ED, whereas group B patients, the control group, were submitted only to hematoma evacuation. Twenty-three (57.5 %) of the patients were males, with an overall age range of 34-79 years (mean 59.3 years). Preoperative Glasgow Coma Scale (GCS) scores in group A ranged from 4 to 13 (mean 7.1), while in group B it ranged from 4 to 12 (mean 6.8). Postoperative hydrocephalus occurred in 3 (15 %) patients in group A and in 4 (20 %) patients in group B, whereas meningitis occurred in one patient (5 %) in group A. The mortality rate was 2 (10 %) patients in group A as compared to 5 (25 %) patients in group B (p = 0.407). High admission GCS (p = 0.0032), younger age (p = 0.0023), smaller hematoma volume (p = 0.044), subcortical hematoma location (p = 0.041), absent or minimal preoperative (p = 0.0068), and postoperative (p = 0.0031) midline shift as well as absent intraventricular extension of the hematoma (p = 0.036) contributed significantly to a better outcome. Selected patients' subgroups who benefited from adding DC and ED to ICH evacuation were age category of 30 to less than 50 (p = 0.0015) and from 50 to less than 70 (p = 0.00619) as well as immediate preoperative GCS from 6 to 8 (p = 0.000436) and from 9 to 12 (p = 0.00774). At 6 months' follow-up, 14 (70 %) patients of group A had favorable outcome as compared to 4 (20 %) patients of group B (p = 0.0015). Adding DC with ED to evacuation of a large hypertensive hemispheric ICH might improve the outcome in selected group of patients.

RCT Entities:   Population Interventions Outcomes