About the study

Optimizing care in children with blunt head trauma

Background to the study

 

Traumatic brain injury (TBI) is a major health concern both in the adult and pediatric population, and a common cause for children to visit the emergency department. Approximately 10% of pediatric TBI are moderate to severe, with a significant incidence

of intracranial injury and GCS 3-13. 80-90% of the children have suffered a minimal to mild TBI with GCS 14-15. The need for neurosurgical intervention in this major

group of patients, with over 3 million emergency department visits in US between 2005 and 2009, is low (0,1-0,2%) but not negligible . The incidence of trauma-related

intracranial abnormalities on computed tomography (CT) of the skull in this group is 4-6%. Nevertheless, if undiagnosed intracranial complications as hematomas may be

life-treathning and/or related to major morbidity.

 

CT of the head will identify these acute complications, but irradiation of the brain result in risk of cancer later in life. Other issues related to CT scanning in this population are the need for sedation (risk of aspiration) and resource allocation. Clinical decision rules (CDRs) as the PECARN-rule2 have been derived in US intendend to aid decision making, but concerns are raised as studies have shown that adoption of this guideline in external populations may increase CT-rate.

 

For Scandinavian use, an evidence and consensus based guideline for initial

management of minor and moderate head trauma in children (SNC 2016) has been developed and published (Fig 1). It stratifies risk for clinically important intracranial

injury, and management recommendations are based upon this risk stratification.

However, before large-scale clinical implementation, a validation and further development study to ensure accuracy and security of the guideline has to be performed.

Material and Methods

 

Primary aim

To perform an internal validation and development study of the new Scandinvian guidelines

for management of minor and moderate head trauma in pediatric patients.

 

Ethics

The study has recieved ethical approval.

 

Setting

This is a pragmatic, prospective observational multicenter (n=22) study in Scandinavia (Sweden, Denmark, Finland, Norway). Children assessed in the emergency

department (ED) due to head trauma during the last 24h with GCS 9-15 are included after informed consent, given none of the exclusion criterias are present (Fig 2). Inclusion of 50 patients is done in a pilot center, full scale inclusion will begin in January 2019.

 

Intervention

The study is observational without intervention and management in ED should follow

hospitals ordinary guideline for traumatic head injury.

 

Data

Medical history, risk factors, signs/symptoms, radiology reports, management in the ED

and symptoms every third month till full recovery are recorded via three sequential

web-based case report forms (Entermedic®).

 

Endpoint

Primary endpoint is a composite of death, neurosurgery, admission > 2 days or

intubation > 1 day due to head injury (clinically important intracranial injury).

 

Statistics

Sample size is calculated to 5300 patients, for a 95% CI regarding sensitivity, specificity

and positive/negative predictive value for the primary endpoint.

Substudies

 

A variety of substudies are planned, some of them are listed below.

 

1. Biomarkers

Collection of capillary or venous blood will be done in 500 patients with GCS 14-15 after traumatic head injury in selected EDs with dedicated pediatric nurses experienced in venipuncture in children.

S100B and additional, at this moment not specified biomarkers will be analysed in batch when all samples are collected.

Goal is to be able to add biomarkers to the guideline and thereby increase sensitivity and specificity for clinically important intracranial injury.

 

2. Comparision with other clincial decision rules

Performance of the SNC 2016 guideline in this Scandinavian cohort will be compared to other validated clincal decsion rules as PECARN, CATCH and CHALICE. An external validation3 and comparison in the APHIRST-cohort has been performed and published 2018.

 

3. User-friendliness

When including a patient, a subset of doctors in the ED will be asked to assess user-friendliness of the SNC 2016 guideline.

 

4. Long-term outcome

Patients will be followed to remission of symptoms via questionnaires sent out every third month. A subset of patients with post-concussive syndrome will be examined by a pediatric neurologist.

References

 

1. Åstrand R, Rosenlund C, Unden J: Scandinavian guidelines for initial management of minor and moderate head trauma in children. BMC medicine (2016), 14(1):33.

 

2. Kuppermann N, et al. Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009; 374(9696):1160–70

 

3. Undén J, et al. External validation of the Scandinavian guidelines for management of minimal, mild and moderate head injuries in children. BMC Medicine (2018) 16:176

 

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