A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke (SPACE SHIELD)

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Stroke

Treatments: Procedure: DCE + CP; Procedure: DCE + SPACE SHIELD

Study type: Interventional

Funder types: Other

Identifiers

NCT06638385

SPACE SHIELD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 19
• ≥ 18 and < 70 years of age
• Availability of consent either from the patient or a legal representative

Exclusion criteria

• Hyperacute need for DCE due to rapid neurological decline
• Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

DCE + SPACE SHIELD

Experimental group

Description:

Patients in the experimental group receive a DCE with implantation of a space-expanding shield.

Treatment:

Procedure: DCE + SPACE SHIELD

DCE + CP

Active Comparator group

Description:

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.

Treatment:

Procedure: DCE + CP