Skip to content
Bored Studies
RecruitingAccepts healthy volunteers

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Thomas Jefferson University · NCT06632587

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
44
US sites recruiting
1
Study start
September 1, 2024
Record last updated
July 23, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Early cranioplasty; Standard-of-care cranioplasty

Conditions: Craniocerebral Trauma; Stroke; Intracranial Hemorrhages

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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")

Recruiting US locations

  • Thomas Jefferson University Hospitals

    Philadelphia, PA 19107

    Site contact: Pious Patel, MD · (215) 955-7000

Study contacts (from the official record)

  • Pious Patel, MD · (215) 955-7000 · pious.patel@jefferson.edu
All neurology studies in Pennsylvania →
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy… (NCT06632587) | Bored Studies