Study characteristics
| Name, publication year and reference number, country, first author surname | Duration from symptoms onset to treatment | Age (years) inclusion; median age years (mean) | n treatment/n control; % females | Rationale for timing of termination | Surgery vs medical management (conservative treatment/standard care) |
|---|---|---|---|---|---|
| DESTINY II 2014,17 Germany, Jüttler | Within 48 hours after the onset of symptoms | Over 60 years; 70 | 47/62; 50% | Anticipated sample size ∼130 patients. Sequential analysis allowed for repeated interim analyses; trial stopped as soon as reached statistical significance for ‘success’ (proportion mRS 4 or less). | Hemicraniectomy and duroplasty vs basic therapy in the ICU for stroke; osmotherapy with the use of mannitol, glycerol or hypertonic hydroxyethyl starch; sedation; intubation and mechanical ventilation; hyperventilation; and administration of buffer solutions. |
| DESTINY I 2007,38 Germany, Jüttler | >12 to <36 hours | 18–60 years; 44.5 | 17/15; 53% | Planned sample size of 188 patients; and after inclusion of 32 patients, the trial was interrupted according to the protocol because reached significance for the 30-day mortality end point. | Hemicraniectomy plus conservative vs osmotherapy; intubation and mechanical ventilation; hyperventilation; venous oxygenation; ICP monitoring; sedation; BP monitoring; head positioning; body core temperature; blood glucose level; fluid management; prophylaxis of DVT. |
| DECIMAL 2007,37 France, Vahedi | Within 24 hours | 18–55 years; (43.4) | 20/18; 53% | Anticipated sample size of 60 patients; sequential analysis planned, stopped after the 38th patient due to slow recruitment, a large difference in mortality between the two groups, and a planned meta-analysis with ongoing European trials38 39 | Hemicraniectomy with or without duroplasty plus standard treatment vs endotracheal intubation; head positioning to an angle of 30°; intravenous fluid restriction; intravenous mannitol or furosemide; intravenous antihypertensive agents; prophylactic use of anticonvulsants. |
| HAMLET 2009,39 Netherlands, Hofmeijer | Within 4 days (96 hours) | 18–60 years; (48.7) | 32/32; 41% | Planned sample size 112, stopped early apparently because of large significant effect. | Hemicraniectomy vs management in ICU consisting of osmotherapy with mannitol or glycerol; intubation and mechanical ventilation; hyperventilation; invasive monitoring of ICP; sedation; muscle relaxants; treatment of elevated BP; elevation of the head to an angle of 30°; maintenance of normothermia, normoglycaemia and normovolaemia. |
| HeADDFIRST 2014 pilot,35 USA and Canada, Frank | Within 4 days (96 hours) | 18–75 years; 54 | 14/10; 38% | Planned sample size was 75 patients, trial stopped after 26 patients randomised because of judgement that ‘we had achieved our aims for the pilot study’ without further details. | Hemicraniectomy and durotomy vs airway management; ventilator settings; BP control and agents; fluid and electrolyte management; gastrointestinal and nutritional management; haematological monitoring and management; ICP monitoring; sedation; use of mannitol; anticonvulsants; prophylaxis againstDVT; and rehabilitation. |
| Decompressive Hemicraniectomy 2012,36 China, Zhao | Within 48 hours | 18–80 years; 64 | 24/23; 28% | Planned sample size was 110; trial was stopped after 47 patients recruited because of large, significant effect. | Hemicraniectomy plus duroplasty vs head positioning; osmotherapy; administration of intravenous mannitol or glycerol; fluid management; intravenous fluid restriction; pulmonary function and airway protection; intubation and mechanical ventilation; cardiac care; BP management; blood glucose management; sedation; no seizure prophylaxis; prevention of DVT and PE. |
| Decompressive Hemicraniectomy 2012,40 Latvia, Slezins | Surgery within 48 hours after onset | Less than and greater than 60 years; (61.5) | 11/13; 43% | No information provided in intended sample size of whether trial went to conclusion | Hemicraniectomy plus best medical treatment group or the best medical treatment (BMT) alone group. No details were provided on the BMT approach. |
BP, blood pressure; DVT, deep-vein thrombosis; ICP, intracranial pressure; ICU, intensive care unit; PE, pulmonary embolism.