Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT06632587
Status
Recruiting
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Conditions

  • Craniocerebral Trauma
  • Intracranial Hemorrhages
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Sep 1, 2024
Status verified
Oct 2024
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Early cranioplasty
    Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.
  • Placebo Comparator: Standard-of-care cranioplasty
    Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.

Primary Outcome Measure

Functional outcome at 6 months post-decompressive hemicraniectomy [ Time Frame: 6 months post-decompressive hemicraniectomy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalsPhiladelphiaPennsylvania19107
Pious Patel, MD
(215) 955-7000

Find similar trials in Philadelphia, PA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Thomas Jefferson University Hospitals· Philadelphia, PA

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