An interventional study of Early prophylactic decompressive hemicraniectomy in Stroke, Ischemic and Cerebral Edema, sponsored by Xuanwu Hospital, Beijing. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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 confirmed benefit in patients >60, improving functional outcomes (mRS 0-4: 38% vs 16%). Guidelines endorse DHC for large infarcts with deterioration.However, significant challenges persist:
DHC is Underutilized: Despite evidence, clinical adoption remains low.Rescue DHC Fails to Improve Outcomes in Post-EVT MCE: Studies report poor functional outcomes (only 20% mRS 0-2) and high mortality (48.6%) with standard medical therapy (SMT) plus rescue DHC after MCE develops. Retrospective data confirms worse outcomes in these patients (mRS 0-2: 16.4% vs 50%; mortality: 46.5% vs 20%) compared to those without MCE. Crucially, rescue DHC itself fails to improve prognosis once MCE is established (mRS 5-6: 64% vs 57.7%; mortality: 48% vs 46.2%).High-Risk Identification: Patients defined as high-risk for MCE (ASPECTS 3-5 + NIHSS≥30 or ASPECTS≤2) have significantly worse 90-day outcomes (mRS 0-2: 23.2% vs 44.6%; mortality: 44% vs 22.7%).Timing is Critical: Rescue DHC is often performed too late, after irreversible neurological damage occurs. Early/Prophylactic DHC, performed before significant edema and herniation develop, offers a potential pathophysiological advantage. It may:Improve cerebral perfusion pressure earlier. Reduce mass effect and edema progression. Mitigate secondary injury (e.g., reduce oxygen-free radicals, excitatory amino acids).Potentially break the ischemic-edema-herniation cycle sooner.Rationale for the Study: While DHC is effective for established MCE in non-EVT contexts and rescue DHC post-EVT is ineffective, high-quality evidence for early prophylactic DHC in high-risk large-core patients after successful EVT is lacking. Current guidelines do not address this specific, high-risk population where MCE incidence is \~50% and outcomes are dismal despite recanalization.
Study Aim: This trial will evaluate the efficacy and safety of early prophylactic decompressive hemicraniectomy compared to standard medical treatment (which includes rescue DHC if MCE develops) in AIS-LVO patients at high risk of MCE (defined by ASPECTS and NIHSS criteria) following successful EVT. The goal is to determine if proactive intervention can improve functional outcomes and reduce mortality in this critically ill population where current strategies fail.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 380 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
3.18 to 75 years of age; 4.Internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA). Patients with involvement of ipsilateral anterior cerebral artery (ACA), MCA or embryonal posterior cerebral artery (PCA) are eligible for inclusion.
5.NIHSS1a ≥ 1 (with the clarification that changes in alertness cannot be attributable to cerebral edema); 6.Meeting any of the following criteria:
Exclusion Criteria:
Clinical Exclusion Criteria
Neuroimaging Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early prophylactic decompressive hemicraniectomy
Procedure: Early prophylactic decompressive hemicraniectomy
Standard medical treatment (with or without rescue decompressive craniectomy if needed).
Early prophylactic decompressive hemicraniectomy (decompressive hemicraniectomy is required to initiate within 6 hours after completion of mechanical thrombectomy and within 4 hours after randomization).
Rate of mRS score of 0-4
Rate of mRS score of 0-4
Time frame: 90 days (±7 days) after randomization
Rate of mRS score of 0-3 Ordinal shift analysis of mRS •Rate of mRS score of 0-2 •Rate of midline shift ≥ 5 mm •Rate of brain herniation Improvement of the NIHSS Rate of neurological deterioration Rate of rescue decompressive hemicraniectomy
mRS score ranges 0-6
Time frame: 90 days (±7 days) after randomization
Ordinal shift analysis of mRS
mRS score ranges 0-6
Time frame: 90 days (±7 days) after randomization
Rate of mRS score of 0-2
mRS score ranges 0-6
Time frame: 90 days (±7 days) after randomization
Rate of midline shift ≥ 5 mm
Based on imaging assessment (e.g., CT, MRI)
Time frame: Within 72 hours after randomization
Rate of brain herniation
e.g., 1 or 2 dilated, fixed pupils; unconsciousness related to edema \[i.e., ≥2 on item 1a on the NIHSS\]; and/or loss of other brain stem reflexes, attributable to edema or herniation according to the Investigator's judgment
Time frame: Within 72 hours after randomization
Improvement of the NIHSS
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Time frame: 5-7 days after randomization or discharge
Rate of neurological deterioration
Defined as increase of NIHSS score ≥4 from baseline
Time frame: 5-7 days after randomization or discharge
Rate of rescue decompressive hemicraniectomy
Control group
Time frame: 5-7 days after randomization or discharge
Length of ICU stay
Residual stay days of ICU
Time frame: Perioperative
Length of hospitalization
Residual stay days of hospitalization
Time frame: Perioperative
Barthel Index
The Barthel Index range from 0 (severe disability) to 100 (no disability)
Time frame: 90 days (±7 days) after randomization
Modified Rankin scale and Barthel Index
The mRS score range from 0 (no disability) to 6 (death), the Barthel Index range from 0 (severe disability) to 100 (no disability)
Time frame: 12 months (±30 days) after randomization
Rate of any intracranial hemorrhage (ICH)
The occurrence of ICH includes the following scenarios: 1. new occurrence of ICH; 2. progression of ICH based on Heidelberg Bleeding Classification.
Time frame: Within 72 hours after randomization
Rate of parenchymal hematoma type 2 intracranial hemorrhage
Time frame: Within 72 hours after randomization
Mortality
Defined as mRS 6
Time frame: 90 days (±7 days) after randomization
Serious Adverse Events
Detailled description noted in study protocol
Time frame: 90 days (±7 days) after randomization
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.