Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632587
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Timing Impact of Early vs Late Cranioplasty on Hemicraniectomy Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
Status:
ACTIVE_NOT_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:
TIMELY
Brief Summary:
This prospective randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy DHC The primary endpoint focuses on comparing the rates of various postoperative complications including infection seizures return to the operating room and the need for ventriculoperitoneal shunting between patients undergoing standard of care cranioplasty 3 months after DHC and those receiving early cranioplasty within 8 weeks
Detailed Description:
This prospective randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy DHC The primary endpoint focuses on comparing the rates of various postoperative complications including infection seizures return to the operating room and the need for ventriculoperitoneal shunting between patients undergoing standard of care cranioplasty 3 months after DHC and those receiving early cranioplasty within 8 weeks
The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury injury defined as acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage This assessment aims to determine whether the timing of cranioplasty influences patients neurological recovery cognitive function and overall quality of life By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty the study seeks to provide valuable insights into the potential benefits of the latter approach
The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC By considering a range of complications and incorporating a robust statistical framework the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies
The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury injury defined as acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage This assessment aims to determine whether the timing of cranioplasty influences patients neurological recovery cognitive function and overall quality of life By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty the study seeks to provide valuable insights into the potential benefits of the latter approach
The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC By considering a range of complications and incorporating a robust statistical framework the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies
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