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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2025-07-23)

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

๐ŸŸข Recruiting Protocol / Phase N/A ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Thomas Jefferson University

๐Ÿฉบ Protocol 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).

Primary Research Facility: Thomas Jefferson University Hospitals (Philadelphia, Pennsylvania)

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๐Ÿ“ Primary Site Map

Site: Thomas Jefferson University Hospitals โ€” Philadelphia, Pennsylvania

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

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๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06632587 โ€ข Last Synced: 2025-07-23
View on ClinicalTrials.gov โ†—
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