Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638385
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACE SHIELD
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None