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
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Aarau, Basilea, Lugano, Luzern, San Gallo
(BASEC)
Sponsor
Prof. Dr. med. Philippe Schucht Insel Gruppe AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Philippe Schucht
+41316640221
space@clutterinsel.chInsel Gruppe AG Inselspital, Universitätsspital Bern Universitätsklinik für Neurochirurgie
(BASEC)
Informazioni generali
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@insel.ch(ICTRP)
Informazioni generali
Inselspital Bern, Department of Neurosurgery
+41316322409
cedric.kissling@insel.ch(ICTRP)
Informazioni generali
Inselspital Bern, Department of Neurosurgery
+41316322409
philippe.schucht@insel.ch(ICTRP)
Informazioni scientifiche
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@insel.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
09.04.2025
(BASEC)
ID di studio ICTRP
NCT06638385 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A space-expanding shield in decompressive hemicraniectomy for stroke – a randomized-controlled multicenter phase III trial (BASEC)
Titolo accademico
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial (ICTRP)
Titolo pubblico
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke (ICTRP)
Malattie studiate
Stroke
(ICTRP)
Intervento studiato
Procedure: DCE + SPACE SHIELDProcedure: DCE + CP
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Criteri di inclusione/esclusione
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
(ICTRP)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Schucht Philippe, MD;C?dric Kissling, MD, cedric.kissling@insel.ch, +41316322409, Inselspital Bern, Department of Neurosurgery, (ICTRP)
ID secondari
SPACE SHIELD (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06638385 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile