NCT06632587 Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
| NCT ID | NCT06632587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Craniocerebral Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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")
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06632587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Craniocerebral Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06632587 currently recruiting?
Yes, NCT06632587 is actively recruiting participants. Contact the research team at pious.patel@jefferson.edu for enrollment information.
Where is the NCT06632587 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06632587 clinical trial?
NCT06632587 is sponsored by Thomas Jefferson University. The trial plans to enroll 44 participants.