RecruitingNot ApplicableNCT06632587

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy

Sponsor

Thomas Jefferson University

Enrollment

44 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke Intracranial Hemorrhages Craniocerebral Trauma

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 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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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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Interventions

PROCEDUREEarly cranioplasty

Cranioplasty 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.

PROCEDUREStandard-of-care cranioplasty

Cranioplasty 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.