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A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
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.
Official title: A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-06-01
Completion Date
2030-06-30
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield.
DCE + CP
Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.
Locations (6)
Kantonsspital Aarau
Aarau, Switzerland
Universitätsspital Basel
Basel, Switzerland
Inselspital Bern, Department of Neurosurgery
Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Ente Ospedaliero Cantonale
Lugano, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, Switzerland