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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early cranioplasty | Active Comparator | Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy. |
|
| Standard-of-care cranioplasty | Placebo Comparator | Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early cranioplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome at 6 months post-decompressive hemicraniectomy | modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy | 6 months post-decompressive hemicraniectomy |
| Functional outcome at 12 months post-decompressive hemicraniectomy | modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy | 12 months post-decompressive hemicraniectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Post-cranioplasty seizure | Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG | 1 month post-cranioplasty |
| Post-cranioplasty hydrocephalus | Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pious Patel, MD | Contact | (215) 955-7000 | pious.patel@jefferson.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospitals | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37166197 | Background | 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. | |
| 28419358 |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
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The collection of outcomes will be performed without regard to the treatment versus control arm.
|
| Standard-of-care cranioplasty | Procedure | 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. |
|
| 1 month post-cranioplasty |
| Post-cranioplasty return to operating room | All-cause return to operating room after cranioplasty | 1 month post-cranioplasty |
| Post-cranioplasty infection | Surgical site or intracranial infection after cranioplasty | 12 months post-cranioplasty |
| Post-cranioplasty disposition | Post-cranioplasty disposition (home, acute rehab, subacute rehab, death) | 12 months post-cranioplasty |
| Post-cranioplasty length of hospital stay | Post-cranioplasty length of hospital stay | 12 months post-cranioplasty |
| Readmission within 30 days post-cranioplasty | Readmission within 30 days post-cranioplasty | 30 days post-cranioplasty |
| Background |
| 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. |
| 35061995 | Background | 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. |
| 36060455 | Background | 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. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |