Space-expanding skull shield used during decompressive surgery for severe stroke

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial

This trial will try placing a custom space‑expanding skull shield at the time of decompressive hemicraniectomy to let the brain swell safely and reduce the need for a second skull-replacement surgery in adults with malignant middle cerebral artery stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 6 sites (Aarau and 5 other locations)
• Trial ID: NCT06638385 on ClinicalTrials.gov

What this trial studies

Malignant middle cerebral artery infarction can cause life-threatening brain swelling that is usually managed by removing a portion of the skull (decompressive hemicraniectomy) followed months later by a second operation to replace the bone (cranioplasty). This study tests a single-stage approach in which a polymethyl‑methacrylate (PMMA) shield is molded and implanted immediately after skull removal to allow swelling while protecting the brain. Participants will receive either decompressive hemicraniectomy plus the space‑expanding shield or decompressive hemicraniectomy followed by standard cranioplasty and will be followed for six months. Enrollment is planned at three Swiss neurosurgery centers between 2025 and 2029.

Who should consider this trial

Good fit: Adults aged 18 to under 70 with malignant middle cerebral artery infarction who meet European guidelines for decompressive hemicraniectomy and can provide consent via next of kin and an independent physician are eligible.

Not a fit: Patients with an immediate hyperacute need for decompression, known allergy to PMMA or gentamicin, pregnancy, prior decompressive or cranioplasty surgery, active cranial or pulmonary infection, or intrinsic coagulopathy are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the single-stage shield approach could eliminate a second surgery and reduce complications such as brain exposure, bone resorption, and the syndrome of the trephined.

How similar studies have performed: A prior prospective cohort suggested the intraoperatively molded shield may prevent several cranioplasty-related complications, but randomized and larger comparative data are limited and the single-stage approach remains relatively novel.

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

Where this trial is running

Aarau and 5 other locations

• Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
• Universitätsspital Basel — Basel, Switzerland (Recruiting)
• Inselspital Bern, Department of Neurosurgery — Bern, Switzerland (Recruiting)
• Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
• Ente Ospedaliero Cantonale — Lugano, Switzerland (Recruiting)
• Kantonsspital St.Gallen — Sankt Gallen, Switzerland (Recruiting)

Study contacts

• Principal investigator: Schucht Philippe, MD — Inselspital Bern, Department of Neurosurgery
• Study coordinator: Philippe Schucht, MD

Conditions Stroke; stroke; bone flap; cranioplasty