Actively Recruiting
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-09
110
Participants Needed
6
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with malignant infarction of the middle cerebral artery confirmed by MRI or CT scans and meeting European guidelines for decompressive hemicraniectomy
- Aged 18 years or older and less than 70 years old
- Consent obtained from a next of kin and an independent physician representing the patient
You will not qualify if you...
- Need for urgent decompressive hemicraniectomy due to rapid neurological decline
- Allergies or hypersensitivity to polymethyl-methacrylate (PMMA) or gentamicin
- Pregnancy or active breastfeeding
- Previous history of decompressive hemicraniectomy or cranioplasty
- Active pulmonary or cranial infections
- Known blood clotting disorders unrelated to medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Kantonsspital Aarau
Aarau, Switzerland
Actively Recruiting
2
Universitätsspital Basel
Basel, Switzerland
Actively Recruiting
3
Inselspital Bern, Department of Neurosurgery
Bern, Switzerland, 3010
Actively Recruiting
4
Luzerner Kantonsspital
Lucerne, Switzerland
Actively Recruiting
5
Ente Ospedaliero Cantonale
Lugano, Switzerland
Actively Recruiting
6
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Actively Recruiting
Research Team
P
Philippe Schucht, MD
CONTACT
K
Kissling Cédric, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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