A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
NCT ID: NCT06638385
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-06-01
2030-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCE + SPACE SHIELD
Patients in the experimental group receive a DCE with implantation of a space-expanding shield.
DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield.
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.
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.
Interventions
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DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield.
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Schucht Philippe, MD
Role: PRINCIPAL_INVESTIGATOR
Inselspital Bern, Department of Neurosurgery
Locations
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Kantonsspital Aarau
Aarau, , Switzerland
Universitätsspital Basel
Basel, , Switzerland
Inselspital Bern, Department of Neurosurgery
Bern, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Ente Ospedaliero Cantonale
Lugano, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPACE SHIELD
Identifier Type: -
Identifier Source: org_study_id
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