StrokeSPACE SHIELDNCT06638385
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
A study testing DCE + SPACE SHIELD and DCE + CP in people with Stroke, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- DCE + SPACE SHIELD and DCE + CP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 1 Jun 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Switzerland6 sites, 6 recruiting
- Recruiting
Kantonsspital Aarau
Aarau
Gerrit A Schubert, MD, +41628386690, gerrit.schubert@insel.ch
- Recruiting
Universitätsspital Basel
Basel
Jehuda Soleman, MD, +4617041330, jehuda.soleman@usb.ch
- Recruiting
Inselspital Bern, Department of Neurosurgery
Bern, 3010
Cédric Kissling, MD, +41316322409, cedric.kissling@insel.ch
Schucht Philippe, MD, +41316322409, philippe.schucht@insel.ch
- Recruiting
Luzerner Kantonsspital
Lucerne
Ulf C Schneider, MD, +41412054504, ulf.schneider@luks.ch
- Recruiting
Ente Ospedaliero Cantonale
Lugano
Andrea Cardia, +41918116283, andrea.cardia@eoc.ch
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen
Hostettler C Isabel, MD, +41714941199, isabel.hostettler@gmail.com
About this study
Official title: A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- DCE + SPACE SHIELD, DCE + CP
- Keywords
- stroke, bone flap, cranioplasty
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE + SPACE SHIELDProcedure or surgery
Patients receive a DCE with implantation of a space-expanding shield.
DCE + CPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DCE + SPACE SHIELD | Experimental | Patients in the experimental group receive a DCE with implantation of a space-expanding shield. Receives: Procedure: DCE + SPACE SHIELD |
| DCE + CP | Active comparator | 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. Receives: Procedure: DCE + CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ranking Scale (mRS) score at 6 months
The primary outcome will be assessed by a blinded, independent, local study nurse.
The sole task of this study nurse will be to assess the mRS based on a short interview with the patient.
Measured: 6 months after surgery
Secondary outcomes (8)
Number of further surgical interventions for ICP control
This includes surgical removal and exchange of the space-expanding shield, implantation of an EVD), surgery for further bony decompression, surgery for removal of hemorrhages or hygroma.
Measured: 6 months after surgery
Occurrence of Hydrocephalus
Any radiological diagnosis of hydrocephalus requiring either a shunting procedure or an EVD, including revision, at least 2 weeks after study inclusion.
Procedures before 2 weeks will qualify as an intervention for ICP control (a. Further surgical interventions for ICP control)
Measured: 6 months after surgery
Number of Infections
Any infection leading to surgical revision and identification of bacteria by bacterial growth in microbacterial analysis from surgically obtained specimen. Wound healing difficulties treated with local treatment only (no surgical revision) will not count as infections.
Measured: 6 months after surgery
Wound healing difficulties
Any surgery under general anaesthesia for wound healing difficulties, unless qualified as infection. The total number of events will be reported as well as the rate of patients with at least one event.
Measured: 6 months after surgery
Syndrome of the trephined
The syndrome of the trephined subsumes various new or worsened neurological deficits attributed to the trephined state: headache, dizziness, fatigue, cognitive decline, decreased consciousness, sensory deficits, motor deficits, speech difficulties. It will be reported on the rate of patients experiencing the syndrome of the trephined, as well as to whether the patient's symptoms recovered following bone-flap re-insertion (fully, partially or not).
Measured: 6 months after surgery
Overall survival at 6 months
Measured: 6 months after surgery
Cosmetic satisfaction at 6 months
The patient will be asked to self-evaluate the overall cosmetic results of the scar, shape of head and visible craniotomy edge using a 5-points Likert scale (very poor - poor - average - good - very good)
Measured: 6 months after surgery
Quality of life score: EQ-5D-5L
EuroQoL 5D-5L questionnaire (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/ Depression (rating from no problems to extreme problems) and health status self rating by patient (Score 0-100, 0 the worst health and 100 the best health))
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jun 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Schucht Philippe, MD, Principal investigator, Inselspital Bern, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638385
- Sponsor's protocol ID
- SPACE SHIELD
- Acronym
- SPACE SHIELD
- Status last verified
- Jul 2025
- First submitted
- 9 Oct 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
- ClinicalTrials.gov ID
- NCT06638385
- Acronym / sponsor ID
- SPACE SHIELD / SPACE SHIELD
- Conditions
- Stroke
- Keywords
- stroke, bone flap, cranioplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCE + SPACE SHIELD | Experimental | Procedure: DCE + SPACE SHIELDPatients in the experimental group receive a DCE with implantation of a space-expanding shield. |
| DCE + CP | Active comparator | Procedure: DCE + CPPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE + SPACE SHIELDPatients receive a DCE with implantation of a space-expanding shield. | Procedure or surgery | DCE + SPACE SHIELD |
| DCE + CPPatients 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. | Procedure or surgery | DCE + CP |
Primary outcome
modified Ranking Scale (mRS) score at 6 months
Time frame: 6 months after surgery
The primary outcome will be assessed by a blinded, independent, local study nurse. The sole task of this study nurse will be to assess the mRS based on a short interview with the patient.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Schucht Philippe, MD principal investigator
Inselspital Bern, Department of Neurosurgery
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCE + SPACE SHIELD and DCE + CP in people with Stroke, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Schucht, MD (+41316322409, philippe.schucht@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Ranking Scale (mRS) score at 6 months (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.