Intracranial Pressure Monitoring for Pediatric Traumatic Brain Injury

(BELA TRIPP Trial)

Recruiting in Seattle (>99 mi)

+8 other locations

Overseen By Kelley Chaddock, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Motor GCS score 6, GCS 3 with fixed pupils, intentional injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 month

428 Participants Needed

Trial Summary

What is the purpose of this trial?

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment CREVICE, Intracranial Pressure Monitoring, ICP Monitoring, ICP, Intracranial Pressure Monitoring, ICP Monitoring for pediatric traumatic brain injury?

Research shows that using intracranial pressure (ICP) monitoring in children with severe traumatic brain injury is linked to lower hospital mortality rates. This suggests that ICP monitoring can be an important tool in improving outcomes for these patients. ^{1 2 3 4 5}

Is intracranial pressure monitoring safe for children with traumatic brain injury?

Intracranial pressure monitoring is commonly used in children with severe head injuries, but there are few studies specifically focused on its safety in the pediatric population. The available research suggests it is a standard part of care, but detailed safety data for children is limited. ^{3 5 6 7 8}

How does intracranial pressure monitoring differ from other treatments for pediatric traumatic brain injury?

Intracranial pressure monitoring is unique because it provides continuous, objective data on the pressure inside the skull, which is crucial for managing severe head injuries in children. Unlike other treatments that may focus on symptoms, this monitoring helps guide therapy by ensuring that interventions for other injuries do not worsen brain pressure. ^{3 4 8 9 10}

Research Team

Randall Chesnut, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for children aged 1-12 who have suffered a non-penetrating traumatic brain injury (TBI) and are admitted to the hospital within 24 hours of the incident. They must have a severe TBI, indicated by a low score on the Glasgow Coma Scale (GCS), and consent from parents or guardians. Children with injuries suspected to be caused intentionally or those with certain unresponsive pupil conditions cannot participate.

Inclusion Criteria

Provision of signed and dated informed consent form by the parent(s) or guardian(s)

I have had a traumatic brain injury that did not penetrate the skull.

I was admitted to the hospital within a day after getting injured.

Exclusion Criteria

I am in a deep coma with no eye response.

Motor GCS score of 6

Injury thought to be intentionally inflicted by a family member or caregiver.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment for severe traumatic brain injury guided by either ICP monitoring or imaging and clinical examination protocols

1 month

Inpatient ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and functional outcomes

6 months

Assessments at 3 and 6 months post-injury

Treatment Details

Interventions

• CREVICE
• ICP

Trial Overview The study compares two ways of treating severe pediatric TBI: one uses invasive monitoring of pressure inside the skull (ICP), while the other follows treatment protocols without such monitoring. The goal is to see which method leads to better recovery outcomes for these young patients.

Participant Groups

Group I: No ICP Monitoring Protocol CREVICE Active Control 1 Intervention

Arm two will use the Consensus-Revised Imaging and Clinical Examination (CREVICE) management protocol for paediatric severe traumatic brain injury based on imaging and clinical examination in the absence of invasive intracranial pressure monitoring

Group II: ICP monitoring based Protocol Active Control 1 Intervention

Arm one will use a consensus-developed management protocol for paediatric severe traumatic brain injury based on recommendations from the Brain Trauma Foundation Guidelines, which uses invasive intracranial pressure monitoring

ICP is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Approved in United States as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Approved in Canada as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Increased intracranial pressure (ICP) is linked to poorer outcomes following traumatic brain injury (TBI), making ICP monitoring crucial for treatment decisions, especially in severe cases.

Current guidelines emphasize maintaining cerebral perfusion pressure and managing elevated ICP, with monitoring being a standard practice in developed countries for pediatric TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of raised intracranial pressure in children with traumatic brain injury. Kukreti, V., Mohseni-Bod, H., Drake, J.[2020]

In a study of 1705 children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring had a significantly lower in-hospital mortality rate of 11% compared to 14.3% overall, suggesting that ICP monitoring may improve outcomes.

The analysis indicated that hospitals with higher rates of ICP monitoring had a 51% lower odds of mortality for treated children, highlighting the potential benefit of ICP monitoring in managing severe TBI, although the overall impact on interhospital mortality variation was modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring among children with severe traumatic brain injury. Alali, AS., Gomez, D., Sathya, C., et al.[2019]

In a study of pediatric trauma patients with severe head injuries, ICP monitoring was associated with a significant reduction in mortality for those with a Glasgow Coma Scale (GCS) score of 3, suggesting a potential survival benefit in this critical subgroup.

Despite the survival advantage, ICP monitoring was infrequently used (only 7.7% of eligible patients) and was linked to longer hospital stays and more ventilator days, indicating a trade-off between monitoring and resource use in pediatric intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: National Trauma Data Bank-Based Review of Outcomes. Alkhoury, F., Kyriakides, TC.[2022]

Intracranial pressure (ICP) monitoring is crucial for managing severely injured children with major head trauma, as demonstrated in a case study of 18 patients with multiple traumas, where it guided appropriate therapy.

The study highlights the importance of early ICP monitoring to ensure optimal care, especially when treatments for other injuries could negatively impact ICP levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring in the management of the pediatric trauma patient. Caniano, DA., Nugent, SK., Rogers, MC., et al.[2019]

In a study of 2116 children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring on admission had a significantly lower in-hospital mortality rate (12.7%) compared to those who did not receive monitoring (17.9%).

The benefits of ICP monitoring were particularly pronounced in children with severe disturbances of consciousness, suggesting that it may be a crucial intervention for improving outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: A Propensity Score Matching Analysis Using a Nationwide Inpatient Database in Japan. Shibahashi, K., Ohbe, H., Matsui, H., et al.[2023]

Continuous monitoring of intracranial pressure (ICP) has been a key practice in managing traumatic brain injury (TBI) for nearly 60 years, but there are no randomized trials confirming its direct benefits.

Clinical evidence suggests that ICP monitoring can lead to improved treatment outcomes when integrated into protocol-driven therapy, although it may also have adverse effects and raises unresolved questions, especially in pediatric cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring for traumatic brain injury in the modern era. Padayachy, LC., Figaji, AA., Bullock, MR.[2021]

In a study of children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring had a significantly better outcome, with only 16.7% experiencing unfavorable results compared to 55% in those who did not have monitoring.

Children without ICP monitoring required more hyperosmolar agents but had shorter ventilation times and ICU stays, suggesting that ICP monitoring may lead to more effective management of severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intracranial pressure monitoring useful in children with severe traumatic brain injury? Arunkumar, S., Devi, BI., Shukla, D., et al.[2018]

In a study of 98 children with severe head injuries, fiberoptic intracranial pressure (ICP) monitoring was found to be safe and effective, with no complications during device insertion and a low infection rate (7% positive cultures) despite prolonged monitoring.

The study reported a 13% mechanical failure rate of the fiberoptic device, but overall, the monitoring technique showed minimal risk of complications and was effective in managing severe head injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors of intracranial pressure monitoring in children with fiberoptic devices: a critical review. Jensen, RL., Hahn, YS., Ciro, E.[2019]

Transcranial Doppler and optic nerve sheath diameter assessments are identified as the most effective noninvasive methods for monitoring intracranial pressure (ICP) in pediatric traumatic brain injury (TBI), based on a review of 27 studies.

While invasive ICP monitoring remains the gold standard, the noninvasive techniques offer promising advantages such as high sensitivity and diagnostic accuracy, potentially making them the future of neurointensive care for children with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Intracranial Pressure Monitoring for Severe Traumatic Brain Injury in Children: A Concise Update on Current Methods. Narayan, V., Mohammed, N., Savardekar, AR., et al.[2018]

In a study of children aged 1 to 12 with severe traumatic brain injury (TBI), intracranial pressure (ICP) monitoring did not show any significant benefits in terms of reducing mortality or the need for cranial surgeries compared to those who were not monitored.

The study found no differences in the duration of mechanical ventilation, length of hospital stay, or outcomes at discharge between the ICP monitored group and the control group, suggesting that ICP monitoring may not be necessary in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children with Severe Traumatic Brain Injury: A Retrospective Study. Banik, S., Rath, GP., Lamsal, R., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Management of raised intracranial pressure in children with traumatic brain injury. [2020]

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

Intracranial pressure monitoring among children with severe traumatic brain injury. [2019]

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

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: National Trauma Data Bank-Based Review of Outcomes. [2022]

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

Intracranial pressure monitoring in the management of the pediatric trauma patient. [2019]

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

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: A Propensity Score Matching Analysis Using a Nationwide Inpatient Database in Japan. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring for traumatic brain injury in the modern era. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Is intracranial pressure monitoring useful in children with severe traumatic brain injury? [2018]

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

Risk factors of intracranial pressure monitoring in children with fiberoptic devices: a critical review. [2019]

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

Noninvasive Intracranial Pressure Monitoring for Severe Traumatic Brain Injury in Children: A Concise Update on Current Methods. [2018]

10. India pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children with Severe Traumatic Brain Injury: A Retrospective Study. [2022]