Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

Cerebral Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555460
• Other study ID #: 2003/44
• Status: Completed
• Phase: N/A
• Start date: January 23, 2003
• Est. completion date: December 30, 2008

Study information

• Verified date: September 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 30, 2008
• Est. primary completion date: December 30, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Herniation
• Infarction
• Infarction, Middle Cerebral Artery

Intervention

Procedure:
• Hemicraniectomy
Large hemicraniectomy and duraplasty

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

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death	Death at 6 month and 1 year	1 year
Secondary	Barthel Index	measured12 months after randomization (defined by a score of 0 to 100; as 100 being the best)	1 year
Secondary	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
Secondary	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