Timing of cranioplasty after decompressive hemicraniectomy: early versus late
Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
This study will test whether having cranioplasty within 8 weeks versus waiting more than 3 months leads to fewer complications and better recovery for adults who had a decompressive hemicraniectomy for traumatic brain injury, stroke, or brain hemorrhage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06632587 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized comparison of early cranioplasty (within 8 weeks) versus standard-of-care cranioplasty (>3 months) after decompressive hemicraniectomy. Adults who underwent DHC for traumatic brain injury, stroke, or intracranial hemorrhage and meet contour and medical criteria are randomized to one of the timing strategies. The trial's primary endpoints compare postoperative complications (infection, seizures, returns to the OR, need for ventriculoperitoneal shunt) and functional outcomes measured at 6 months post-injury. The study is conducted at Thomas Jefferson University Hospitals with standardized surgical and follow-up protocols.
Who should consider this trial
Good fit: Adults aged 18 or older who had decompressive hemicraniectomy for traumatic brain injury, stroke, or intracranial hemorrhage, whose cranial flap meets contour Class A or B and who are medically optimized for surgery are ideal candidates.
Not a fit: Patients with active systemic or cranial infections, those judged unsuitable for early cranioplasty by their neurosurgeon, or those who die before 8 weeks are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, earlier cranioplasty could lower complication rates, reduce the need for additional procedures, and improve neurological recovery and quality of life.
How similar studies have performed: Observational and retrospective studies have reported mixed signals suggesting potential benefits of earlier cranioplasty, but randomized evidence is limited, making this randomized comparison important.
Eligibility criteria
Show full inclusion / exclusion 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")
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospitals — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Pious Patel, MD
- Email: pious.patel@jefferson.edu
- Phone: (215) 955-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.