An interventional study of Early cranioplasty and Standard-of-care cranioplasty in Craniocerebral Trauma, Stroke and Intracranial Hemorrhages, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's planned enrollment of 44 is below the median of 60 across 137 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.
Procedure: Early cranioplasty
Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.
Procedure: 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. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.
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.
Functional outcome at 6 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy
Time frame: 6 months post-decompressive hemicraniectomy
Functional outcome at 12 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy
Time frame: 12 months post-decompressive hemicraniectomy
Post-cranioplasty seizure
Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG
Time frame: 1 month post-cranioplasty
Post-cranioplasty hydrocephalus
Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion
Time frame: 1 month post-cranioplasty
Post-cranioplasty return to operating room
All-cause return to operating room after cranioplasty
Time frame: 1 month post-cranioplasty
Post-cranioplasty infection
Surgical site or intracranial infection after cranioplasty
Time frame: 12 months post-cranioplasty
Post-cranioplasty disposition
Post-cranioplasty disposition (home, acute rehab, subacute rehab, death)
Time frame: 12 months post-cranioplasty
Post-cranioplasty length of hospital stay
Post-cranioplasty length of hospital stay
Time frame: 12 months post-cranioplasty
Readmission within 30 days post-cranioplasty
Readmission within 30 days post-cranioplasty
Time frame: 30 days post-cranioplasty
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