DECIMAL Trial: Early Decompressive Craniectomy in Malignant MCA Infarction
In patients aged 18-55 with malignant MCA infarction, does early decompressive hemicraniectomy plus medical therapy reduce mortality at 6 months compared with medical therapy alone?
Vahedi et al. (Stroke 2007) · doi:10.1161/STROKEAHA.107.485235 · 38 patients
Population
Included
- Age 18-55 years
- Clinical and imaging signs of malignant MCA infarction (diffusion-restricted volume greater than 145 mL or greater than 50% of MCA territory)
- Randomization within 24 hours of symptom onset (extended to 30 hours in some patients)
- NIHSS greater than 15
Age & timing
- Patients between 18 and 55 years of age
- Included within 24 hours of a malignant MCA infarction
Clinical & imaging (all 3 required)
- A National Institutes of Health Stroke Scale score >=16, including a score >=1 on item 1a (level of consciousness)
- Brain computed tomography ischemic signs involving >50% of the MCA territory
- A diffusion-weighted imaging (DWI) infarct volume >145 cm3
Excluded
- Age greater than 55 years
- Significant pre-existing disability (mRS greater than 1)
- Bilateral fixed dilated pupils or other signs of herniation before randomization
- Hemorrhagic transformation before randomization
- Major comorbidities limiting life expectancy
Key exclusions
- Preexisting significant disability defined by a modified Rankin Scale (mRS) score >=2
- A significant contralateral infarction
- A severe secondary hemorrhagic infarction involving >50% of the MCA territory
- Any known coagulopathy (including use of recombinant tissue-type plasminogen activator)
- Life expectancy <3 years
- Any serious illness that could confound treatment assessment
- Pregnancy
- Any magnetic resonance imaging (MRI) contraindication
Source: Vahedi et al., Stroke 2007· Retrieved 2026-06-09
Mortality Outcome — 6-Month Survival
38 patients; decompressive hemicraniectomy vs medical therapy alone
6-Month Survival
Primary endpoint mRS less than or equal to 3 at 6 months was not statistically significant (P=0.18) due to small sample size of 38 patients. Mortality reduction is the secondary endpoint that reached significance.
Study Arms
- Agent
- Decompressive hemicraniectomy with duraplasty
- Duration
- Within 30 h of symptom onset; no later than 6 h after randomization. Mean delay 20.5 h (range 7 to 43)
- Co-interventions
- Standard medical therapy per published guidelines for early management of ischemic stroke, identical to the no-surgery group
Large hemicraniectomy removing a bone flap as large as possible (ipsilateral to the stroke), including temporal, frontal, parietal, and some occipital bones; the dura was opened. Duraplasty was left to the discretion of the neurosurgeon and was performed in 11 of 20 patients. Cranioplasty was not performed before the 6-month visit unless the patient had already reached an mRS <=3.
- Agent
- Conservative medical management
- Co-interventions
- Same standard medical therapy protocol applied in both groups
Standard medical therapy based on published guidelines for early management of ischemic stroke. Hypothermia discouraged; continuous invasive ICP monitoring not recommended. Endotracheal intubation recommended for severely increased ICP. Measures to avoid factors exacerbating edema (hyperthermia, hyperglycemia); head of bed elevated at 30 degrees. IV fluid restriction of 500 mL/d with normal saline; IV glucose solutions discouraged. IV mannitol (0.25 to 0.5 g/kg) or furosemide only if condition worsened from edema. IV antihypertensives when systolic BP >220 mm Hg or diastolic BP >120 mm Hg. Prophylactic anticonvulsants at center discretion. No patient in this group underwent decompressive surgery during follow-up.
Trial Design
Type
- Multicenter randomized controlled trial
- Early decompressive craniectomy plus medical therapy vs medical therapy alone
- Patients aged 18-55 years with malignant MCA infarction
- Sequential design with blinded primary endpoint assessment
Timeline
France, 2001-2005; stopped early for pooled analysis
N
38
Enrollment
38 patients at multiple French centers (planned 70; stopped early for pooled analysis). Sequential design with blinded primary endpoint assessment. Patients aged 18-55 with malignant MCA infarction. Randomization within 24-30 hours of onset. Published Stroke 2007.
Bedside Pearl
DECIMAL shows hemicraniectomy prevents death in malignant MCA infarction for patients under 56 years. Before consent, tell the family explicitly: most survivors will have severe disability (mRS 4-5) and will not return to independent function. Surgery saves life, not function. The pooled analysis (DECIMAL, DESTINY, HAMLET within 48 hours) provides the most reliable estimate of benefit and risk. Use it for family counseling.
See also
Trial lineage
Hemicraniectomy for malignant MCA infarction
Three near-simultaneous European RCTs (DECIMAL, DESTINY, HAMLET) established that decompressive hemicraniectomy reduces mortality in younger patients with space-occupying MCA infarction. The pooled analysis underpins the AHA/ASA Class I recommendation in patients up to 60 years. DESTINY II later extended the question to patients over 60, where survival is preserved but most survivors have moderate-to-severe disability.
- 2007DECIMAL Trial· this pageNEUTRAL
- 2007DESTINY TrialNEUTRAL
- 2009HAMLET TrialNEUTRAL
- 2014DESTINY II TrialPOSITIVE