Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Functional outcome at 6 months post-decompressive hemicraniectomy [Срок оценки: 6 months post-decompressive hemicraniectomy]
• Functional outcome at 12 months post-decompressive hemicraniectomy [Срок оценки: 12 months post-decompressive hemicraniectomy]

Вторичные конечные точки (7)

• Post-cranioplasty seizure [Срок оценки: 1 month post-cranioplasty]
• Post-cranioplasty hydrocephalus [Срок оценки: 1 month post-cranioplasty]
• Post-cranioplasty return to operating room [Срок оценки: 1 month post-cranioplasty]
• Post-cranioplasty infection [Срок оценки: 12 months post-cranioplasty]
• Post-cranioplasty disposition [Срок оценки: 12 months post-cranioplasty]
• Post-cranioplasty length of hospital stay [Срок оценки: 12 months post-cranioplasty]
• Readmission within 30 days post-cranioplasty [Срок оценки: 30 days post-cranioplasty]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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")

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Thomas Jefferson University Hospitals — Philadelphia

Публикации

• 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. 2023 Jul 1;25(1):72-80. doi: 10.1227/ons.0000000000000689. Epub 2023 May 5. PMID 37166197
• 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. PMID 28419358
• 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. PMID 35061995
• 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. PMID 36060455

Идентификаторы

NCT: NCT06632587 · iRISID-2024-3103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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