Actively Recruiting
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Led by Thomas Jefferson University · Updated on 2025-07-23
44
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of acute traumatic injury or increased intracranial pressure due to stroke or intracranial hemorrhage requiring decompressive hemicraniectomy
- Cranial flap classified as Craniectomy Contour Class A or B at 4 weeks after surgery
- Medically optimized for general anesthesia and surgery
You will not qualify if you...
- Active systemic infection between weeks 6 and 8 after decompressive hemicraniectomy (e.g., pneumonia, urinary tract infection, soft tissue infection, bacteremia)
- Cranial infection during the post-decompressive hemicraniectomy period
- Determined by attending neurosurgeon as not appropriate for early cranioplasty
- Death before 8 weeks post-injury (acute traumatic injury or brain injury from stroke or intracranial hemorrhage)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
P
Pious Patel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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