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Early vs. Late Cranioplasty After Brain Injury

This study is looking at the best time to perform cranioplasty, a surgery to restore the skull after a life-saving procedure called decompressive hemicraniectomy (DHC). DHC is done to relieve pressure in the brain after injuries like craniocerebral trauma, stroke, or bleeding in the brain. Researchers want to see if having cranioplasty earlier (within 8 weeks) compared to later (more than 3 months after DHC) affects complications like infection or seizures, and how well people recover functionally at 6 and 12 months after DHC. You might be able to join if you are an adult (18 or older) who had a DHC due to a brain injury or condition.

Study design
This is a randomized study with 44 participants. It compares two different timings for cranioplasty: early (within 8 weeks) versus standard-of-care (more than 3 months after DHC).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' functional outcomes will be checked at 6 months and 12 months after their decompressive hemicraniectomy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06632587

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Recruiting
NAAges 18+InterventionalTreatment
Thomas Jefferson University
~44 participants
Updated 2025-07-23 on ClinicalTrials.gov
What's tested:Early cranioplastyStandard-of-care cranioplasty

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional outcome at 6 months post-decompressive hemicraniectomy
Measured over 6 months post-decompressive hemicraniectomy
+1 more outcome measured

Conditions

Craniocerebral Trauma
Stroke
Intracranial Hemorrhages

Explore related trials

Head InjuryIntracranial HemorrhageStroke

NCT06632587

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Thomas Jefferson University Hospitals

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Pious Patel, MD
[email protected]
(215) 955-7000
Email the study team

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Eligibility criteria

Inclusion

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

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")

What this trial measures

  • Functional outcome at 6 months post-decompressive hemicraniectomy6 months post-decompressive hemicraniectomy

    modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy

  • Functional outcome at 12 months post-decompressive hemicraniectomy12 months post-decompressive hemicraniectomy

    modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy