A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat patients who have had a serious type of stroke called a malignant stroke. Normally, doctors perform a surgery called decompressive hemicraniectomy to relieve pressure in the brain, followed by a second surgery to put the skull back in place. In this study, researchers want to see if they can do both steps in one surgery by using a special device called a space-expanding shield. This shield is custom-made for each patient and aims to help manage the pressure in the brain more effectively.

To be eligible for this trial, participants need to be between the ages of 18 and 70 and have a specific type of stroke that can be seen on certain brain scans. They also need to be able to give consent for their participation or have someone else do it for them. However, people who have certain medical conditions, are pregnant or breastfeeding, or have had similar surgeries in the past will not be included. If you or a loved one is considering taking part in this study, you'll receive detailed information about the surgery and what to expect during the process. The trial is not yet recruiting participants, but it represents a potential advancement in how strokes are treated.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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