A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DCE + SPACE SHIELD, DCE + CP.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Overview
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.
Interventions
- Procedure DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield. - Procedure DCE + 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.
Primary outcome measures
- modified Ranking Scale (mRS) score at 6 months [Time frame: 6 months after surgery]
Secondary outcome measures (8)
- Number of further surgical interventions for ICP control [Time frame: 6 months after surgery]
- Occurrence of Hydrocephalus [Time frame: 6 months after surgery]
- Number of Infections [Time frame: 6 months after surgery]
- Wound healing difficulties [Time frame: 6 months after surgery]
- Syndrome of the trephined [Time frame: 6 months after surgery]
- Overall survival at 6 months [Time frame: 6 months after surgery]
- Cosmetic satisfaction at 6 months [Time frame: 6 months after surgery]
- Quality of life score: EQ-5D-5L [Time frame: 6 months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 6 centers
- Kantonsspital Aarau — Aarau
- Universitätsspital Basel — Basel
- Inselspital Bern, Department of Neurosurgery — Bern
- Luzerner Kantonsspital — Lucerne
- Ente Ospedaliero Cantonale — Lugano
- Kantonsspital St.Gallen — Sankt Gallen
Identifiers
NCT: NCT06638385 · SPACE SHIELD