NCT06638385Recruiting
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Stroke
- NCT number
- NCT06638385
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Jun 2025 to the primary completion date, 31 Dec 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known coagulopathy independent of medication
Other illness
- 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
Other
- Hyperacute need for DCE due to rapid neurological decline
- Pregnancy and active breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kantonsspital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Inselspital Bern, Department of Neurosurgery Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| Ente Ospedaliero Cantonale Coordinator of this site? Confirm its status | Lugano | Switzerland | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.