Recruiting

Cranioplasty Timing

Sponsor:

Thomas Jefferson University

Code:

NCT06632587

Conditions

Craniocerebral Trauma

Stroke

Intracranial Hemorrhages

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Early cranioplasty

Standard-of-care cranioplasty

Study Details

Brief 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).

Conditions

Craniocerebral Trauma

Stroke

Intracranial Hemorrhages

Study ID

NCT06632587

Start date

Sep 1, 2024

Status verified date

Oct, 2024

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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")

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early cranioplasty

Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.

placebo comparator: Standard-of-care cranioplasty

Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.

Interventions

Early cranioplasty

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.

Standard-of-care cranioplasty

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.

Primary outcome measure

  • Functional outcome at 6 months post-decompressive hemicraniectomy [ Time Frame: 6 months post-decompressive hemicraniectomy ]
  • Functional outcome at 12 months post-decompressive hemicraniectomy [ Time Frame: 12 months post-decompressive hemicraniectomy ]

Central Contacts and Locations

Central contacts

Pious Patel, MD

(215) 955-7000pious.patel@jefferson.edu

Locations

Thomas Jefferson University Hospitals

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Pious Patel, MD

(215) 955-7000

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jul 23, 2025

Last verified

Oct, 2024

Keywords

  • Decompressive hemicraniectomy
  • cranioplasty
  • cranial trauma
  • stroke
  • intracranial hemorrhage
  • intracerebral hemorrhage
  • neurosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-07-23.