Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

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
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
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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")
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Early cranioplastyEarly cranioplastyCranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.
Standard-of-care cranioplastyStandard-of-care cranioplastyCranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.
Primary Outcome Measures
NameTimeMethod
Functional outcome at 6 months post-decompressive hemicraniectomy6 months post-decompressive hemicraniectomy

modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy

Functional outcome at 12 months post-decompressive hemicraniectomy12 months post-decompressive hemicraniectomy

modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy

Secondary Outcome Measures
NameTimeMethod
Post-cranioplasty seizure1 month post-cranioplasty

Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG

Post-cranioplasty hydrocephalus1 month post-cranioplasty

Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion

Post-cranioplasty return to operating room1 month post-cranioplasty

All-cause return to operating room after cranioplasty

Post-cranioplasty infection12 months post-cranioplasty

Surgical site or intracranial infection after cranioplasty

Post-cranioplasty disposition12 months post-cranioplasty

Post-cranioplasty disposition (home, acute rehab, subacute rehab, death)

Post-cranioplasty length of hospital stay12 months post-cranioplasty

Post-cranioplasty length of hospital stay

Readmission within 30 days post-cranioplasty30 days post-cranioplasty

Readmission within 30 days post-cranioplasty

Trial Locations

Locations (1)

Thomas Jefferson University Hospitals

🇺🇸

Philadelphia, Pennsylvania, United States

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