A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

ClinicalTrials.gov ID

NCT06638385

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

110Estimated

Last Update Posted

Jul 9, 2025Actual

Start Date

Jun 1, 2025Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Jun 30, 2030Estimated

Official Title

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

Brief 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.

Detailed Description

Background:

A malignant cerebral infarction causes edema resulting in a threatening increase of the intracranial pressure (ICP). Standard of care is a surgical removal of a part of the skull above the ischemic brain, the so-called decompressive hemicraniectomy (DCE). DCE allows the brain to swell, after detumescence of the brain parenchyma (usually several months later) the patients undergo a second surgery with implantation of either their own preserved bone flap or a bone flap substitute (a procedure referred to as cranioplasty (CP)).

Objective:

Despite its proven life-saving benefits, the strategy of DCE followed by CP carries several risks, among others

• Exposure of the brain parenchyma
• Various neurological deficits subsumed under the syndrome of the trephined
• Bone resorption: As shown in a previous prospective cohort study the above-mentioned risks may be prevented using an intraoperatively molded space-expanding protective shield, which is implanted and fixed directly after having performed (a so far customary) DCE. This shield allows the brain to swell while still providing protection.

SPACE SHIELD investigates whether the single-stage strategy of implanting a space-expanding shield represents a viable alternative to the standard DCE followed by CP."

Methods:

The inclusion of patients is planned to take place from January 2025 to December 2029. The study duration for the individual patients is 6 months. While the intervention group will be treated with the above-described space-expanding shield the control group will be treated with the customary DCE and following CP. The CP will be performed either with the original bone flap stored in customary manner or with a PMME bone flap. Examinations of the patients are planned after 1 - 7 days, 6 weeks, 3 months and 6 months after the initial surgery.

• Stroke

• DCE + SPACE SHIELD
• DCE + CP

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

jehuda.soleman@usb.ch+4617041330

ulf.schneider@luks.ch+41412054504

andrea.cardia@eoc.ch+41918116283

isabel.hostettler@gmail.com+41714941199

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