Evaluating a Space-Expanding Shield as a Single Surgery Alternative to Standard Skull Removal and Replacement in Stroke Patients Aged 18 to 70

What this Trial Is About

This research aims to compare two surgical approaches for patients experiencing increased intracranial pressure caused by malignant stroke. It investigates whether using a single surgery with an individually molded space-expanding shield can be a viable alternative to the standard decompressive hemicraniectomy followed by a second surgery called cranioplasty. The study is planned as a randomized, controlled, multicenter trial to evaluate these methods in stroke patients aged 18 to under 70. Participants will be randomly assigned to one of two groups. The experimental group will receive decompressive hemicraniectomy with implantation of a space-expanding shield that allows brain swelling while providing protection in a single surgery. The control group will undergo the standard decompressive hemicraniectomy without the shield and later undergo cranioplasty about 90 days after the initial surgery. Follow-up examinations are scheduled at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. During the study, participants will undergo evaluations including neurological assessments and imaging to monitor recovery and complications. Researchers will measure outcomes such as the modified Rankin Scale score at 6 months, number of additional surgeries for intracranial pressure control, infections, wound healing, syndrome of the trephined, survival, cosmetic satisfaction, and quality of life. The total duration of participation for each patient is 6 months, with safety and recovery closely monitored throughout.

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke