Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Purpose
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).
Conditions
- Craniocerebral Trauma
- Stroke
- Intracranial Hemorrhages
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC) - Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689) - Medically optimized for general anesthesia/surgery
Exclusion Criteria
- Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia) - Cranial infection in the post-DHC period - Patient deemed not appropriate for early cranioplasty by attending neurosurgeon - Patient mortality prior to 8 weeks post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure causing brain injury secondary to stroke or intracranial hemorrhage")
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The collection of outcomes will be performed without regard to the treatment versus control arm.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Early cranioplasty |
Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy. |
|
|
Placebo Comparator Standard-of-care cranioplasty |
Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy. |
|
Recruiting Locations
Philadelphia, Pennsylvania 19107
Pious Patel, MD
(215) 955-7000
More Details
- Status
- Recruiting
- Sponsor
- Thomas Jefferson University
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.