Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction: A Randomized, Controlled Study

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Herniation
• Intervention / Treatment: Procedure: Hemicraniectomy; Other: Conservative medical therapy

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Decompressive surgery; 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.	Procedure: Hemicraniectomy; Large hemicraniectomy and duraplasty; Other Names: Surgical decompression
ACTIVE_COMPARATOR: 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.	Other: Conservative medical therapy; Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Timur Köse, PhD, Biostatistic Department, Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2003
• Primary Completion (ACTUAL): December 30, 2007
• Study Completion (ACTUAL): December 30, 2008

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: infarction, hemicraniectomy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Infarction; Infarction; Infarction, Middle Cerebral Artery
• Other Study ID Numbers: 2003/44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 3 months after publication data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No