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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Early cranioplasty
Procedure/SurgeryCranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.
Standard-of-care cranioplasty
Procedure/SurgeryCranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Early cranioplastyActive comparator 1 intervention
Group B: Standard-of-care cranioplastyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional outcome at 6 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy
Time frame
6 months post-decompressive hemicraniectomy2
Functional outcome at 12 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy
Time frame
12 months post-decompressive hemicraniectomySecondary outcomes
1
Post-cranioplasty seizure
Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG
Time frame
1 month post-cranioplasty2
Post-cranioplasty hydrocephalus
Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion
Time frame
1 month post-cranioplasty3
Post-cranioplasty return to operating room
All-cause return to operating room after cranioplasty
Time frame
1 month post-cranioplasty4
Post-cranioplasty infection
Surgical site or intracranial infection after cranioplasty
Time frame
12 months post-cranioplastySponsors and contacts
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Source ClinicalTrials.gov