Tests a space-expanding shield after surgery for severe stroke swelling
Tests a custom shield implant in adults with dangerous brain swelling from a large stroke.
Plain-language title generated from the registry record
Registry title: A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Key facts
- Where
- Aarau, Basel, Bern, Lucerne, Lugano, and Sankt Gallen, SwitzerlandSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06638385, who can take part
Where in Switzerland
- Kantonsspital AarauAarau, SwitzerlandTaking people
- Universitätsspital BaselBasel, SwitzerlandTaking people
- Inselspital Bern, Department of NeurosurgeryBern, SwitzerlandTaking people
- Luzerner KantonsspitalLucerne, SwitzerlandTaking people
- Ente Ospedaliero CantonaleLugano, SwitzerlandTaking people
- Kantonsspital St. GallenSankt Gallen, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT06638385
- Record updated
- 9 July 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Known coagulopathy independent of medication; Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy; Known gentamicin allergy; Patients with a former history of DCE and/or CP; Active pulmonary or cranial infection; Hyperacute need for DCE due to rapid neurological decline; Pregnancy and active breast-feeding.