Minor Head Injury Clinical Trial
It is difficult for Pediatric Emergency Department providers to recognize clinically
significant head injuries that are likely to require neurosurgical intervention or close
monitoring from those that can be safely discharged.
Research Question How do a combination of education and an animated picture depicting the
PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT
scans?
Design This is a within subject, repeated measures study design.
Status | Completed |
Enrollment | 746 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Patients presenting to Children's ED will be included if they: - Are between 0 and 18 years of age (inclusive) - Receive a discharge diagnosis of head injury - Present to the ED within 24 hours of the head injury - GCS of 14 or greater Exclusion Criteria: - Patients will be excluded if they : - Had a CT scans done in an outside transferring institution - Have obvious penetrating head injuries - Had a trivial injury mechanisms such as ground-level falls or walking or running into stationary objects - Have no signs or symptoms of head trauma other than scalp abrasions and lacerations. - Have known brain tumors, pre-existing neurological disorders complicating assessment, ventricular shunts, bleeding disorders |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota |
United States | Children's Hospitals and Clinics of Minnesota | Twin Cities | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance to the PECARN CT Scan Head Injury rules | 3 months | Yes | |
Secondary | Decreased rate of CT scans | 3 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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