Craniocerebral Trauma, Intracranial Hemorrhages, Stroke
Conditions
Keywords
Decompressive hemicraniectomy, cranioplasty, cranial trauma, stroke, intracranial hemorrhage, intracerebral hemorrhage, neurosurgery
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.
Interventions
PROCEDUREEarly 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.
PROCEDUREStandard-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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The collection of outcomes will be performed without regard to the treatment versus control arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome at 6 months post-decompressive hemicraniectomy | 6 months post-decompressive hemicraniectomy | modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy |
| Functional outcome at 12 months post-decompressive hemicraniectomy | 12 months post-decompressive hemicraniectomy | modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-cranioplasty return to operating room | 1 month post-cranioplasty | All-cause return to operating room after cranioplasty |
| Post-cranioplasty infection | 12 months post-cranioplasty | Surgical site or intracranial infection after cranioplasty |
| Post-cranioplasty seizure | 1 month post-cranioplasty | Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG |
| Post-cranioplasty length of hospital stay | 12 months post-cranioplasty | Post-cranioplasty length of hospital stay |
| Readmission within 30 days post-cranioplasty | 30 days post-cranioplasty | Readmission within 30 days post-cranioplasty |
| Post-cranioplasty disposition | 12 months post-cranioplasty | Post-cranioplasty disposition (home, acute rehab, subacute rehab, death) |
| Post-cranioplasty hydrocephalus | 1 month post-cranioplasty | Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion |
Countries
United States
Contacts
Primary ContactPious Patel, MD
Outcome results
None listed