Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

Ege University

Status: Completed

Conditions: Cerebral Herniation

Treatments: Other: Conservative medical therapy; Procedure: Hemicraniectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04555460

2003/44

Details and patient eligibility

About

This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0 [no symptoms] to 6 [death]). Secondary outcome included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. The study was performed according to Consolidated Standards of Reporting Trials (CONSORT).

Full description

Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a National Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (DWI) infarct volume >150cm3. The first patient was enrolled in January 2003 and the last patient in December 2007. An independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. Patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.

Enrollment: 151 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A National Institutes of Health Stroke Scale score ≥16
• A score ≥1 for item 1a (level of consciousness)
• Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory
• Diffusion-weighted imaging infarct volume >150cm3

Exclusion criteria

• Prestroke modified Rankin score score ≥2
• Prestroke score on the Barthel Index <95
• Score on the Glasgow Coma Scale <6
• Both pupils fixed and dilated
• Any other coincidental brain lesion that might affect outcome
• Plasminogen activator in the 12 h before randomisation
• Space-occupying hemorrhagic transformation of the infarct
• Pregnancy
• Life expectancy <3 years
• Other serious illness that might affect outcome
• Known coagulopathy or systemic bleeding disorder
• Contraindication for anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Decompressive surgery

Active Comparator group

Description:

Decompressive surgery was performed with a large hemicraniectomy that removed, ipsilateral to the stroke, a bone flap as large as possible including temporal, frontal, parietal, and some occipital squama.

Treatment:

Procedure: Hemicraniectomy

Conservative medical therapy

Active Comparator group

Description:

Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke. Administration of intravenous mannitol (0.25 to 0.5 g/kg) or furosemide was given only in patients whose condition was rapidly worsening because of brain edema, without additional recommendations on loading doses.

Treatment:

Other: Conservative medical therapy