Timing of Cranioplasty for Traumatic Brain Injury

(TIMELY Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Active infection, Cranial infection, Mortality, others

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Early cranioplasty for Traumatic Brain Injury?

Research suggests that performing cranioplasty earlier can improve recovery of cognitive and functional abilities in patients with brain injuries. Additionally, ultra-early cranioplasty may reduce the risk of certain complications like hydrocephalus (fluid buildup in the brain) compared to conventional timing. ^{1 2 3 4 5}

Is cranioplasty generally safe for humans?

Cranioplasty is generally safe, but it can have complications like infections, improperly fitting implants, and hydrocephalus (fluid buildup in the brain). The timing of the procedure and the materials used can affect the risk of these complications. ^{4 5 6 7 8}

How does early cranioplasty differ from standard-of-care cranioplasty for traumatic brain injury?

Early cranioplasty, performed soon after the initial surgery, may lead to better outcomes by reducing the risk of complications like hydrocephalus (fluid buildup in the brain) and shortening surgery time compared to standard-of-care cranioplasty, which is done later. ^{1 2 4 5 9}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for individuals who have had a decompressive hemicraniectomy after suffering from conditions like intracranial hemorrhage, traumatic brain injury, or stroke. Participants should be suitable candidates for either early cranioplasty (within 8 weeks) or standard-of-care cranioplasty (more than 3 months later).

Inclusion Criteria

My skull shape after surgery fits within the specified classes.

I am cleared by my doctor for surgery under general anesthesia.

Exclusion Criteria

I have had a brain infection after my decompressive hemicraniectomy.

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")

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Cranioplasty

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

8 weeks

Standard-of-care Cranioplasty

Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy

3 months

Follow-up

Participants are monitored for safety and effectiveness after cranioplasty

12 months

Treatment Details

Interventions

• Early cranioplasty
• Standard-of-care cranioplasty

Trial Overview The study compares the outcomes of two different timings for cranioplasty surgery: 'early' within 8 weeks post-surgery and 'standard-of-care' which is performed more than 3 months afterwards. It looks at complications such as infection and seizures, and whether patients need additional surgeries.

Participant Groups

Group I: Early cranioplasty Active Control 1 Intervention

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

Group II: Standard-of-care cranioplasty Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Super early cranial repair improves the prognosis of patients with craniocerebral injury. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Early Cranioplasty on the Restoration of Cognitive and Functional Impairments. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Towards a core outcome set for cranioplasty following traumatic brain injury and stroke 'A systematic review of reported outcomes'. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultra-Early Cranioplasty versus Conventional Cranioplasty: A Retrospective Cohort Study at an Academic Level 1 Trauma Center. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

Factors predicting complications following cranioplasty. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Excessive Hemostasis on the Scalp Increases Superficial Surgical Site Infection Rate in Cranioplasty. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Early cranioplasty vs. late cranioplasty for the treatment of cranial defect: A systematic review. [2018]