Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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")
Trial design
Treatments tested in this trial
- Early cranioplasty
- Standard-of-care cranioplasty
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov