Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Not Applicable

Active, not recruiting

• Conditions: Craniocerebral Trauma; Stroke; Intracranial Hemorrhages
• Interventions: Procedure: Early cranioplasty; Procedure: Standard-of-care cranioplasty

• Registration Number: NCT06632587
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-09-26
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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")

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cranioplasty	Early cranioplasty	Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.
Standard-of-care cranioplasty	Standard-of-care cranioplasty	Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Post-cranioplasty seizure	1 month post-cranioplasty	Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG
Post-cranioplasty hydrocephalus	1 month post-cranioplasty	Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion
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 disposition	12 months post-cranioplasty	Post-cranioplasty disposition (home, acute rehab, subacute rehab, death)
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

Trial Locations

Locations (1)

Thomas Jefferson University Hospitals; 🇺🇸 Philadelphia, Pennsylvania, United States