Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

NCT06632587 | Recruiting DMC

• 1 other identifier: iRISID-2024-3103
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Craniocerebral Trauma; Stroke; Intracranial Hemorrhages

Keywords

Decompressive hemicraniectomy; cranioplasty; cranial trauma; stroke; intracranial hemorrhage; intracerebral hemorrhage; neurosurgery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Post-cranioplasty seizure

  1 month post-cranioplasty

• Post-cranioplasty hydrocephalus

  1 month post-cranioplasty

• Post-cranioplasty return to operating room

  1 month post-cranioplasty

• Post-cranioplasty infection

  12 months post-cranioplasty

• Post-cranioplasty disposition

  12 months post-cranioplasty

Study Arms (2)

Early cranioplasty

ACTIVE COMPARATOR

Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.

Procedure: Early cranioplasty

Standard-of-care cranioplasty

PLACEBO COMPARATOR

Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.

Procedure: Standard-of-care cranioplasty

Interventions

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.

Early cranioplasty

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.

Standard-of-care cranioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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")

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (4)

• 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 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.

  PMID: 28419358 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.

  PMID: 35061995 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.

  PMID: 36060455 BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma; Stroke; Intracranial Hemorrhages; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pious Patel, MD

CONTACT

(215) 955-7000; pious.patel@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The collection of outcomes will be performed without regard to the treatment versus control arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2024-10

Locations

US (1)