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

ISRCTN	ISRCTN81464462
DOI	https://doi.org/10.1186/ISRCTN81464462
Protocol serial number	N/A
Sponsor	Institution of Medicine, Karolinska Hospital (Sweden)
Funders	All funding comes from public funds and peer-reviewed grants, including:, The Swedish Research Council, Expo/Stockholm County Council, The Vardal Foundation, The Health Research Council in the South-East of Sweden, Apoteket AB, The Swedish Society of Medicine, The Thelma Zoéga Foundation, Region Skåne, The Gorthon Foundation

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jean-Luc af Geijerstam
Scientific

Octopus Trial Co-ordinator
Karolinska Hospital
Institution of Medicine
Unit of Clinical Epidemiology
Stockholm
SE-171 76
Sweden

Phone	+46-8-517 797 05
Email	octopus@medks.ki.se

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	OCTOPUS study
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mild head injury
Intervention	1. Admission for in-hospital observation 2. Urgent CT for all patients, early discharge if normal findings
Intervention type	Other
Primary outcome measure(s)	Study 1: Patient function at 3 months (Extended Glasgow Outcome Scale [GOSE]). Study 2: Economic costs.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2004

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	2500
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2001
Date of final enrolment	31/01/2004

Octopus Trial Co-ordinator

Stockholm
SE-171 76
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on cost comparison	02/09/2006		Yes	No
Results article	results on medical outcome	02/09/2006		Yes	No