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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: philippe.schucht@insel.ch
• Phone: +41316322409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.