Clinical trial NCT06638385: A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Official title: A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
bone flap
cranioplasty
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background:

A malignant cerebral infarction causes edema resulting in a threatening increase of the intracranial pressure (ICP). Standard of care is a surgical removal of a part of the skull above the ischemic brain, the so-called decompressive hemicraniectomy (DCE). DCE allows the brain to swell, after detumescence of the brain parenchyma (usually several months later) the patients undergo a second surgery with implantation of either their own preserved bone flap or a bone flap substitute (a procedure referred to as cranioplasty (CP)).

Objective:

Despite its proven life-saving benefits, the strategy of DCE followed by CP carries several risks, among others

* Exposure of the brain parenchyma
* Various neurological deficits subsumed under the syndrome of the trephined
* Bone resorption: As shown in a previous prospective cohort study the above-mentioned risks may be prevented using an intraoperatively molded space-expanding protective shield, which is implanted and fixed directly after having performed (a so far customary) DCE. This shield allows the brain to swell while still providing protection.

SPACE SHIELD investigates whether the single-stage strategy of implanting a space-expanding shield represents a viable alternative to the standard DCE followed by CP."

Methods:

The inclusion of patients is planned to take place from January 2025 to December 2029. The study duration for the individual patients is 6 months. While the intervention group will be treated with the above-described space-expanding shield the control group will be treated with the customary DCE and following CP. The CP will be performed either with the original bone flap stored in customary manner or with a PMME bone flap. Examinations of the patients are planned after 1 - 7 days, 6 weeks, 3 months and 6 months after the initial surgery.

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

Primary outcomes:
measure: modified Ranking Scale (mRS) score at 6 months
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Number of further surgical interventions for ICP control
timeFrame: 6 months after surgery
measure: Occurrence of Hydrocephalus
timeFrame: 6 months after surgery
measure: Number of Infections
timeFrame: 6 months after surgery
measure: Wound healing difficulties
timeFrame: 6 months after surgery
measure: Syndrome of the trephined
timeFrame: 6 months after surgery
measure: Overall survival at 6 months
timeFrame: 6 months after surgery
measure: Cosmetic satisfaction at 6 months
timeFrame: 6 months after surgery
measure: Quality of life score: EQ-5D-5L
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern, Department of Neurosurgery
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: Inselspital Bern, Department of Neurosurgery
name: Schucht Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References: