Clinical trial NCT06632587: Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Official title: Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Craniocerebral Trauma
Stroke
Intracranial Hemorrhages
Keywords: Decompressive hemicraniectomy
cranioplasty
cranial trauma
stroke
intracranial hemorrhage
intracerebral hemorrhage
neurosurgery
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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).

The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage"). This assessment aims to determine whether the timing of cranioplasty influences patients' neurological recovery, cognitive function, and overall quality of life. By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty, the study seeks to provide valuable insights into the potential benefits of the latter approach.

The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC. By considering a range of complications and incorporating a robust statistical framework, the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies.

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")

Primary outcomes:
measure: Functional outcome at 6 months post-decompressive hemicraniectomy
timeFrame: 6 months post-decompressive hemicraniectomy
measure: Functional outcome at 12 months post-decompressive hemicraniectomy
timeFrame: 12 months post-decompressive hemicraniectomy
Secondary outcomes:
measure: Post-cranioplasty seizure
timeFrame: 1 month post-cranioplasty
measure: Post-cranioplasty hydrocephalus
timeFrame: 1 month post-cranioplasty
measure: Post-cranioplasty return to operating room
timeFrame: 1 month post-cranioplasty
measure: Post-cranioplasty infection
timeFrame: 12 months post-cranioplasty
measure: Post-cranioplasty disposition
timeFrame: 12 months post-cranioplasty
measure: Post-cranioplasty length of hospital stay
timeFrame: 12 months post-cranioplasty
measure: Readmission within 30 days post-cranioplasty
timeFrame: 30 days post-cranioplasty
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospitals
state: Pennsylvania
Study officials:
References:
citation: Patel PD, Khanna O, Gooch MR, Glener SR, Mouchtouris N, Momin AA, Sioutas G, Amllay A, Barsouk A, El Naamani K, Yudkoff C, Wyler DA, Jallo JI, Tjoumakaris S, Jabbour PM, Harrop JS. Clinical Outcomes After Ultra-Early Cranioplasty Using Craniectomy Contour Classification as a Patient Selection Criterion. Oper Neurosurg (Hagerstown). 2023 Jul 1;25(1):72-80. doi: 10.1227/ons.0000000000000689. Epub 2023 May 5.
citation: Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182.
citation: Eaton JC, Greil ME, Nistal D, Caldwell DJ, Robinson E, Aljuboori Z, Temkin N, Bonow RH, Chesnut RM. Complications associated with early cranioplasty for patients with traumatic brain injury: a 25-year single-center analysis. J Neurosurg. 2022 Jan 21;137(3):776-781. doi: 10.3171/2021.11.JNS211557. Print 2022 Sep 1.
citation: Sethi A, Chee K, Kaakani A, Beauchamp K, Kang J. Ultra-Early Cranioplasty versus Conventional Cranioplasty: A Retrospective Cohort Study at an Academic Level 1 Trauma Center. Neurotrauma Rep. 2022 Aug 1;3(1):286-291. doi: 10.1089/neur.2022.0026. eCollection 2022.