Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

NCT04555460 | Completed DMC

• 1 other identifier: 2003/44
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Herniation

Keywords

infarction, hemicraniectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Death

  1 year

• Barthel Index

  1 year

• National Institute of Health Stroke Scale (NIHSS)

  1 year

• Stroke Impact Scale 2.0 (SIS)

  1 year

Study Arms (2)

Decompressive surgery

ACTIVE COMPARATOR

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

Conservative medical therapy

ACTIVE COMPARATOR

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

Interventions

Hemicraniectomy PROCEDURE

Large hemicraniectomy and duraplasty

Also known as: Surgical decompression

Decompressive surgery

Conservative medical therapy OTHER

Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke

Also known as: Control group

Conservative medical therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infarction

Interventions

Decompression, Surgical; Control Groups

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Timur Köse, PhD

  Biostatistic Department, Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 18, 2020
• Study Start: January 23, 2003
• Primary Completion: December 30, 2007
• Study Completion: December 30, 2008
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)