Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Launched by THOMAS JEFFERSON UNIVERSITY · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of when to perform a surgery called cranioplasty, which involves placing a bone flap back over the skull after a procedure called decompressive hemicraniectomy (DHC). DHC is done to relieve pressure on the brain after serious injuries like trauma or stroke. The trial aims to find out if doing cranioplasty early (within 8 weeks after DHC) leads to fewer complications, such as infections, seizures, or the need for further surgery, compared to the standard timing of more than 3 months after DHC.

To be eligible for this study, participants need to be adults aged 18 or older who have had a significant brain injury or stroke that required DHC. They also need to be medically stable for surgery and have a specific type of skull shape that is suitable for cranioplasty after 4 weeks. Participants will be monitored for any complications and their recovery outcomes to help determine the best timing for this important surgery. This trial is currently active but not recruiting new participants.

Gender

ALL

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")