RECRUITING

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

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Conditions

Craniocerebral TraumaStrokeIntracranial HemorrhagesDecompressive hemicraniectomycranioplastycranial traumaintracranial hemorrhageintracerebral hemorrhageneurosurgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy

Quick Facts

Study Start:2024-09-01
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06632587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689)
  3. * Medically optimized for general anesthesia/surgery
  1. * Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia)
  2. * Cranial infection in the post-DHC period
  3. * Patient deemed not appropriate for early cranioplasty by attending neurosurgeon
  4. * 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")

Contacts and Locations

Study Contact

Pious Patel, MD
CONTACT
(215) 955-7000
pious.patel@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Craniocerebral Trauma
  • Stroke
  • Intracranial Hemorrhages