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

July 3, 2025 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kissling Cédric, MD
  • Phone Number: +41316322409
  • Email: space@insel.ch

Study Locations

  • Switzerland
      • Aarau, Switzerland
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
      • Basel, Switzerland
        • Recruiting
        • Universitätsspital Basel
        • Contact:
      • Bern, Switzerland, 3010
      • Lugano, Switzerland
        • Recruiting
        • Ente Ospedaliero Cantonale
        • Contact:
      • Luzern, Switzerland
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
      • St.Gallen, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCE + SPACE SHIELD
Patients in the experimental group receive a DCE with implantation of a space-expanding shield.
Procedure: DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of further surgical interventions for ICP control
Time Frame: 6 months after surgery
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.
6 months after surgery
Number of Infections
Time Frame: 6 months after surgery
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.
6 months after surgery
Syndrome of the trephined
Time Frame: 6 months after surgery
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).
6 months after surgery
Overall survival at 6 months
Time Frame: 6 months after surgery
6 months after surgery
Cosmetic satisfaction at 6 months
Time Frame: 6 months after surgery
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)
6 months after surgery
Occurrence of Hydrocephalus
Time Frame: 6 months after surgery

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)
6 months after surgery
Wound healing difficulties
Time Frame: 6 months after surgery
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.
6 months after surgery
Quality of life score: EQ-5D-5L
Time Frame: 6 months after surgery
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))
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Schucht Philippe, MD, Inselspital Bern, Department of Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPACE SHIELD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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