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Observation or computed tomography (CT) of mild head injury in Sweden. A randomised clinical trial concerning effects and costs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81464462
Enrollment
2500
Registered
2003-10-16
Start date
2001-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild head injury Injury, Occupational Diseases, Poisoning

Interventions

1. Admission for in-hospital observation 2. Urgent CT for all patients, early discharge if normal findings

Sponsors

Institution of Medicine, Karolinska Hospital (Sweden)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2500 patients with mild head injury, defined as short-term loss of consciousness and/or amnesia as a result of head trauma. Upon presentation in the emergency department, the patient should have regained a normal level of consciousness as measured by the Glasgow Coma Scale (GCS 15) and have normal neurological findings. Inclusion criteria: 1. Head trauma within the past 24 hours 2. Age 6 years or older 3. Confirmed or suspected amnesia or brief loss of consciousness 4. Normal neurological examination 5. No associated injuries that require admission

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Study 1: Patient function at 3 months (Extended Glasgow Outcome Scale [GOSE]). Study 2: Economic costs.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 11, 2026