Timing of Cranioplasty for Traumatic Brain Injury

(TIMELY Trial)

Overseen By Pious Patel, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal timing for cranioplasty, a surgery to repair the skull, following a brain injury. Researchers aim to determine whether performing this surgery earlier (within 8 weeks) or later (after 3 months) affects complications such as infections or seizures. Individuals who have undergone decompressive hemicraniectomy (a surgery to relieve brain pressure) due to a traumatic injury or similar condition may be suitable candidates, particularly if they are prepared for another surgery. The trial seeks to identify the safest and most effective timing for this follow-up procedure. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance surgical outcomes for future patients.

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 prior data suggests that the timing of cranioplasty is safe for patients with traumatic brain injury?

Research has shown that early cranioplasty is generally safe for individuals with traumatic brain injuries. Studies have found that performing this procedure one to two months after the initial surgery does not increase complications. In fact, some research suggests that early cranioplasty might reduce the risk of certain post-surgery issues compared to delaying the procedure.

One study found no increase in problems, such as infections or seizures, when cranioplasty was performed sooner rather than later. Another analysis found no major differences in complication rates between early and late procedures.

Overall, early cranioplasty appears well-tolerated, with most patients experiencing no significant problems. This evidence suggests the procedure is safe for those considering participation in a trial involving early cranioplasty. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the timing of cranioplasty for traumatic brain injury because it could significantly impact recovery outcomes. Unlike the standard practice of waiting over three months to perform cranioplasty, early cranioplasty is done within eight weeks after the initial surgery. This approach might help reduce complications and improve brain healing by restoring skull integrity sooner. By investigating this timing, researchers hope to discover whether earlier intervention can lead to better recovery and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for traumatic brain injury?

This trial will compare early cranioplasty with standard-of-care cranioplasty for patients with traumatic brain injury. Research has shown that performing a cranioplasty within 8 weeks after a decompressive hemicraniectomy can improve brain function and thinking skills. Studies have found that patients undergoing this surgery earlier tend to recover better than those who have it later. One study found that the risk of complications, such as seizures, is low when the surgery is performed early. Additionally, the chance of developing hydrocephalus is also low. These findings suggest that early cranioplasty might be more effective in aiding recovery and reducing complications after a traumatic brain injury. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537585/

The impact of early cranioplasty on neurological function ... Early cranioplasty is beneficial for the postoperative recovery of patients with traumatic brain injury. It improves neurological function, enhances cognitive ...

2. thejns.org thejns.org/view/journals/j-neurosurg/141/4/article-p895.xml

Early versus delayed cranioplasty after decompressive ... The aim of this study was to compare the outcomes of early (≤ 90 days) and delayed (> 90 days) cranioplasty following decompressive craniectomy ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875022011433

Predictors of Clinical Outcomes in Autologous Cranioplasty Seizures after cranioplasty have been reported to range from 2.9%–29%. No patients with traumatic brain injury developed post-cranioplasty seizure in our ...

4. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0318841&type=printable

Comparative effectiveness of different surgical timings on ... Early cranioplasty is associ- ated with greater neurological improvement: A systematic review and meta-analysis. Neurosurgery. 2018;82(3):278–88 ...

5. journals.lww.com journals.lww.com/neurosurgery/fulltext/2022/04001/475_complications_associated_with_early.267.aspx

475 Complications Associated With Early Cranioplasty for... A total of 54 patients underwent ultra-early cranioplasty. Among the total cohort, the mean rate of post-op hydrocephalus was 2.8%, the rate of seizure was 4.6% ...

6. thejns.org thejns.org/view/journals/j-neurosurg/137/3/article-p776.xml

Complications associated with early cranioplasty for ... In this cohort of patients with TBI, early cranioplasty, including ultra-early procedures, was not associated with higher rates of complications.

7. kjnt.org kjnt.org/pdf/10.13004/jknts.2011.7.2.74

Safety and Efficacy of Early Cranioplasty after ... 8) Decompressive craniectomy re- duces the risk of death in patients experiencing severe brain edema. However, patients with large cranial defects may ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025004250

The timing of cranioplasty and the risk of postoperative ... The results of the meta-analysis suggested that CP performed within 1 month (vs. CP performed beyond 1 month) after DC was associated with a reduced risk of PCs ...

9. mdpi.com mdpi.com/2077-0383/14/12/4176

Comparison of Complications in Early and Late ... Conclusions: Cranioplasty within 90 days, considered early, had no statistically significant differences in complication rates compared to late cranioplasty.