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
Secondary identifying numbers	N/A

Submission date: 27/08/2003
Registration date: 16/10/2003
Last edited: 25/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Study 1: Patient function at 3 months (Extended Glasgow Outcome Scale [GOSE]). Study 2: Economic costs.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2001
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	2,500
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

Locations

Countries of recruitment

Sweden

Study participating centre

Octopus Trial Co-ordinator

Stockholm
SE-171 76
Sweden

Sponsor information

Institution of Medicine, Karolinska Hospital (Sweden)
Hospital/treatment centre

Unit of Clinical Epidemiology
Stockholm
SE-171 76
Sweden

Phone	+46-8-517 797 05
Email	octopus@medks.ki.se
"ROR"	https://ror.org/00m8d6786

Funders

Funder type

Research council

All funding comes from public funds and peer-reviewed grants, including:

No information available

The Swedish Research Council

No information available

Expo/Stockholm County Council

No information available

The Vardal Foundation

No information available

The Health Research Council in the South-East of Sweden

No information available

Apoteket AB

No information available

The Swedish Society of Medicine

No information available

The Thelma Zoéga Foundation

No information available

Region Skåne

No information available

The Gorthon Foundation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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