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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Aarau, Basel, Genf, Lugano, Luzern, St Gallen
(BASEC)
Sponsor
Prof. Dr. med. Philippe Schucht Insel Gruppe AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Cédric Kissling
+41316322409
cedric.kissling@clutterinsel.chInsel Gruppe AG Inselspital, Universitätsspital Bern Universitätsklinik für Neurochirurgie
(BASEC)
Allgemeine Auskünfte
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Allgemeine Auskünfte
Inselspital Bern, Department of Neurosurgery
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Wissenschaftliche Auskünfte
Inselspital Bern, Department of Neurosurgery,
+41316322409
cedric.kissling@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.04.2025
(BASEC)
ICTRP Studien-ID
NCT06638385 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A space-expanding shield in decompressive hemicraniectomy for stroke – a randomized-controlled multicenter phase III trial (BASEC)
Wissenschaftlicher Titel
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial (ICTRP)
Öffentlicher Titel
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke (ICTRP)
Untersuchte Krankheit(en)
Stroke (ICTRP)
Untersuchte Intervention
Procedure: DCE + SPACE SHIELDProcedure: DCE + CP (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Schucht Philippe, MD;C?dric Kissling, MD, cedric.kissling@insel.ch, +41316322409, Inselspital Bern, Department of Neurosurgery, (ICTRP)
Sekundäre IDs
SPACE SHIELD (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06638385 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar