Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06638385

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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