A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID: NCT06638385
Run by: Insel Gruppe AG, University Hospital Bern
People needed: 110
Starts: 2025-06-01
Expected to finish: 2030-06-30
Last updated by the study team: 2025-07-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.