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Study identifier: NCT07118345 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial

Condition: Stroke, Ischemic · Cerebral Edema  ·  Sponsor: Xuanwu Hospital, Beijing

PhaseNA
Planned participants380
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Early Decompressive Hemicraniectomy for High-Risk Large Ischemic Core Stroke Post-EVTAcute Ischemic Stroke (AIS), particularly Anterior Circulation Large Vessel Occlusion (LVO), is a major cause of global disability and death. While endovascular thrombectomy (EVT) is the standard first-line treatment for LVO, outcomes remain poor in patients with large ischemic cores (ASPECTS ≤5). Despite high recanalization rates (\>90%), only 14-30% achieve functional independence (mRS 0-2) at 90 days, with 33-50% dead or severely disabled (mRS 5-6). Outcomes worsen dramatically with larger core volumes (e.g., only 4.4% functional independence with cores ≥150mL in SELECT2).A critical complication is Malignant Cerebral Edema (MCE), affecting \~50% of large-core patients post-EVT. MCE triggers a vicious cycle of rising intracranial pressure, reduced perfusion, and brain herniation. It drastically worsens prognosis: functional independence rates plummet (13.3% vs 51.2% without MCE), mortality significantly increases (OR=7.96, p=0.001), and functional outcomes deteriorate (OR=7.83, p=0.008). Strong predictors include low ASPECTS (\<7) and large infarct volume.Decompressive Hemicraniectomy (DHC) is a life-saving intervention for MCE. Landmark trials (DESTINY, DECIMAL, HAMLET) and their meta-analysis show DHC within 24 hours in patients aged 18-60 significantly increases 12-month survival (78% vs 29%, ARR 50%) and rates of ambulatory independence (mRS ≤3: 43% vs 21%, ARR 23%). DESTINY II confirme…

This description comes directly from the study's public registry record.

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Locations (2)

Xuanwu Hospital, Capital Medical University.Beijing, ChinaNot Yet Recruiting
Liaocheng Brain HospitalShandong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07118345