RecruitingNot ApplicableNCT06638385

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

110 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke
≥ 18 and < 70 years of age
Availability of consent from a next of kin and from the patient represented by an independent physician

Exclusion Criteria7

Hyperacute need for DCE due to rapid neurological decline
Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy
Known gentamicin allergy
Pregnancy and active breast-feeding
Patients with a former history of DCE and/or CP
Active pulmonary or cranial infection
Known coagulopathy independent of medication

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Interventions

PROCEDUREDCE + SPACE SHIELD

Patients receive a DCE with implantation of a space-expanding shield.

PROCEDUREDCE + CP

Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.