A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,300
- 试验地点
- 16
- 主要终点
- Number of participants with "clinically important intracranial injury (CIII)"
研究概览
简要总结
Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed.
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department.
The main research question is:
- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes?
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group.
The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).
详细描述
Design:
This is a pragmatic, prospective, multicentre, observational study of children presenting with mild or moderate traumatic brain injury (TBI) in a general or paediatric emergency department (ED) at hospitals in Scandinavia. A complete data set for analysis including predictor variables and outcome data for the six guidelines included in the study will be registered (SNC2016, PECARN, CATCH, CHALICE, PREDICT, NICE23). There are no interventions as the study is observational. Attending physicians and nurses are instructed to manage children in accordance with the hospital's ordinary guidelines and follow local treatment traditions.
Study setting and population:
The study will be set in Sweden and Norway. Hospitals with different trauma capacities will participate; invitations are sent to units which on daily basis mange children with TBI in their department. Efforts are made to establish a representative distribution in participating centres. The coordinating centre is Halmstad Hospital in southern Sweden.
Data registration and follow-up:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <18 years.
- •Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.
- •Within 24 hours of trauma.
- •Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.
排除标准
- •Patient and/or guardian does not wish to participate in the study.
- •Patient included in other study that may affect the management/treatment in the emergency department.
- •Penetrating head injury (as those will always receive a CT scan).
- •Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).
- •The patient is not a citizen in the participating country and hence difficult to follow up.
结局指标
主要结局
Number of participants with "clinically important intracranial injury (CIII)"
时间窗: Within 1 week of injury.
Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.
次要结局
- Number of participants with death due to head injury(Within one week; within 3 months.)
- Number of participants with neurosurgery due to TBI(Within 1 week of injury.)
- Number of participants with need for sedation or intubation during cCT exam(Within 3 months from injury)
- Concentration of specific biomarkers in serum and saliva(Sampling at admission to the emergency department)
- Number of participants with extended "clinical observation in ED"(Within the first day (24 hours) of injury)
- Number of participants intubated due to TBI(Within 3 months from injury)
- Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )(Within one week from trauma)
- Number of participants with CT findings(Within 1 week of injury.)
- Duration of clinical observation(Within 1 week of injury.)
- Number of participants referred for cranial CT (cCT) due to head injury.(Within 3 months from injury)
- Number of participants referred for a follow up (re-)cCT due to clinical deterioration.(Within 3 months from injury)
- Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).(Within 3 months from injury)
- Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").(Within one week from trauma)
- Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")(Within one week from trauma)
- Number of participants reassessed or readmitted due to TBI(Within four weeks from trauma)
- Number of participants admitted to in-hospital observation > 2 days(Within 3 months from injury)
- Number of participants admitted to in-hospital observation(Within 3 months from injury)
- Number of participants with significant CT findings(Within 1 week of injury.)
- Duration of intubation due to TBI(Within 3 months from injury)
- Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").(Within one week from trauma)
- Clinicial utility SNC16 rule(At admission to the emergency department.)
- Number of participants with presence of outcome as defined by CHALICE-rule ("clinically significant intracranial injury" or "presence of skull fracture" or "admission to hospital").(Within one week from trauma)
- Number of participants transported to other hospital due to TBI(Within 3 months from injury)
- Time to full recovery(<1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months)
研究者
Fredrik Wickbom
Principal Investigator
Halmstad County Hospital