Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

Not Applicable

Completed

• Conditions: Cerebral Herniation
• Interventions: Procedure: Hemicraniectomy; Other: Conservative medical therapy

• Registration Number: NCT04555460
• Lead Sponsor: Ege University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2003-01-23
• Primary Completion: 2007-12-30
• Study Completion: 2008-12-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decompressive surgery	Hemicraniectomy	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.
Conservative medical therapy	Conservative medical therapy	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.

Primary Outcome Measures

Name	Time	Method
modified Rankin score 0-3	1 year	Slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale 2.0 (SIS)	1 year	The score of each domain was calculated as 100 being the best, with a range of 0-100.
Death	1 year	Death at 6 month and 1 year
Barthel Index	1 year	measured12 months after randomization (defined by a score of 0 to 100; as 100 being the best)
National Institute of Health Stroke Scale (NIHSS)	1 year	measured12 months after randomization (The maximum possible score is 42, with the minimum score being a 0)

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey