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Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

NCT04555460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2020-09-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Timur Köse, PhD · Biostatistic Department, Ege University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-23
Primary Completion
2007-12-30
Completion
2008-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555460 on ClinicalTrials.gov