Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
- Conditions
- Interventions
- Registration Number
- NCT06632587
- Lead Sponsor
- Thomas Jefferson University
- 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...
- 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...
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early cranioplasty Early cranioplasty Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy. Standard-of-care cranioplasty Standard-of-care cranioplasty Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.
- Primary Outcome Measures
Name Time Method Functional outcome at 6 months post-decompressive hemicraniectomy 6 months post-decompressive hemicraniectomy modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy
Functional outcome at 12 months post-decompressive hemicraniectomy 12 months post-decompressive hemicraniectomy modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy
- Secondary Outcome Measures
Name Time Method Post-cranioplasty seizure 1 month post-cranioplasty Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG
Post-cranioplasty hydrocephalus 1 month post-cranioplasty Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion
Post-cranioplasty return to operating room 1 month post-cranioplasty All-cause return to operating room after cranioplasty
Post-cranioplasty infection 12 months post-cranioplasty Surgical site or intracranial infection after cranioplasty
Post-cranioplasty disposition 12 months post-cranioplasty Post-cranioplasty disposition (home, acute rehab, subacute rehab, death)
Post-cranioplasty length of hospital stay 12 months post-cranioplasty Post-cranioplasty length of hospital stay
Readmission within 30 days post-cranioplasty 30 days post-cranioplasty Readmission within 30 days post-cranioplasty
Trial Locations
- Locations (1)
Thomas Jefferson University Hospitals
🇺🇸Philadelphia, Pennsylvania, United States