A space-expanding skull cap replacement in relieving unilateral removal of the skull cap in the context of stroke treatment – a randomized controlled multicenter study
Résumé de l'étude
In this study, we investigate whether an implant, individually crafted for each patient, placed directly after the removal of the skull bone represents an alternative: The implant provides slightly more underlying space compared to the original skull bone, allowing the affected hemisphere of the brain to swell. Thus, it can be placed immediately after the removal of the original skull bone and offers immediate protection of the underlying brain tissue – which means no second operation is required. - Group 1 (experimental group) will be treated with the new surgical method: In the first and only operation, immediately following the removal of the skull cap above the affected hemisphere, the individually shaped, space-expanding skull cap implant will be inserted. - Group 2 (control group) receives the standard treatment consisting of the surgical removal of the skull cap above the affected hemisphere, as well as the insertion of either the original skull bone or a matching implant in a second operation after the swelling of the affected brain part has subsided.
(BASEC)
Intervention étudiée
In this study, we investigate whether an implant, individually crafted for each patient, placed directly after the removal of the skull bone represents an alternative:
The implant provides slightly more underlying space compared to the original skull bone, allowing the affected hemisphere of the brain to swell. Thus, it can be placed immediately after the removal of the original skull bone and offers immediate protection of the underlying brain tissue – which means no second operation is required.
(BASEC)
Maladie en cours d'investigation
Stroke
(BASEC)
- Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging – meeting the European guidelines for decompressive hemicraniectomy (DCE) in stroke - Age: ≥ 18 and < 70 years - Consent from the patient or a legal representative (BASEC)
Critères d'exclusion
- Hyperacute need for DCE due to rapid neurological decline - Contraindications for the use of polymethylmethacrylate (PMMA), e.g., known hypersensitivity, allergy - Known gentamicin allergy - Pregnancy and active breastfeeding - Patients with a history of DCE and/or CP - Active lung or skull infection - Known drug-independent coagulopathy (BASEC)
Lieu de l’étude
Aarau, Bâle, Genève, Lugano, Luzern, St-Gall
(BASEC)
Sponsor
Prof. Dr. med. Philippe Schucht Insel Gruppe AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Cédric Kissling
+41316322409
cedric.kissling@clutterinsel.chInsel Gruppe AG Inselspital, Universitätsspital Bern Universitätsklinik für Neurochirurgie
(BASEC)
Informations générales
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Informations générales
Inselspital Bern, Department of Neurosurgery
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Informations scientifiques
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
09.04.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06638385 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A space-expanding shield in decompressive hemicraniectomy for stroke – a randomized-controlled multicenter phase III trial (BASEC)
Titre académique
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial (ICTRP)
Titre public
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke (ICTRP)
Maladie en cours d'investigation
Stroke (ICTRP)
Intervention étudiée
Procedure: DCE + SPACE SHIELDProcedure: DCE + CP (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 19
- = 18 and < 70 years of age
- Availability of consent either from the patient or a legal representative
Exclusion Criteria:
- Hyperacute need for DCE due to rapid neurological decline
- Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known
hypersensitivity, 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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
modified Ranking Scale (mRS) score at 6 months (ICTRP)
Number of further surgical interventions for ICP control;Occurrence of Hydrocephalus;Number of Infections;Wound healing difficulties;Syndrome of the trephined;Overall survival at 6 months;Cosmetic satisfaction at 6 months;Quality of life score: EQ-5D-5L (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Schucht Philippe, MD;C?dric Kissling, MD, cedric.kissling@insel.ch, +41316322409, Inselspital Bern, Department of Neurosurgery, (ICTRP)
ID secondaires
SPACE SHIELD (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06638385 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible