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Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

RecruitingNAAges 18 Years - anyAllThomas Jefferson University
NCT06632587 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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")
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What it tests

  • Early cranioplasty
  • Standard-of-care cranioplasty
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Where

1 site
Thomas Jefferson University Hospitals
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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