Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

• ClinicalTrials.gov Identifier: NCT04555460
• Recruitment Status: Completed
• First Posted: September 18, 2020
• Last Update Posted: September 18, 2020
• Sponsor: Ege University
• Information provided by (Responsible Party): Prof. Dr. Emre Kumral, Ege University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cerebral Herniation	Procedure: Hemicraniectomy; Other: Conservative medical therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction: A Randomized, Controlled Study
• Actual Study Start Date: January 23, 2003
• Actual Primary Completion Date: December 30, 2007
• Actual Study Completion Date: December 30, 2008

Arms and Interventions

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 Name: 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 Name: Control group

Outcome Measures

Primary Outcome Measures :

1. modified Rankin score 0-3 [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Ege University

İzmir, Turkey

Sponsors and Collaborators

Ege University

Investigators

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

More Information

• Responsible Party: Prof. Dr. Emre Kumral, Prof. MD, Ege University
• ClinicalTrials.gov Identifier: NCT04555460
• Other Study ID Numbers: 2003/44
• First Posted: September 18, 2020
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 3 months after publication data will be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Emre Kumral, Ege University:

infarction, hemicraniectomy

Additional relevant MeSH terms:

Infarction, Middle Cerebral Artery; Infarction; Ischemia; Pathologic Processes; Necrosis; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases