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Observation or computed tomography (CT) of mild head injury in Sweden. A randomised clinical trial concerning effects and costs
ISRCTN ISRCTN81464462
DOI 10.1186/ISRCTN81464462
ClinicalTrials.gov identifier
EudraCT number
Public title Observation or computed tomography (CT) of mild head injury in Sweden. A randomised clinical trial concerning effects and costs
Scientific title
Acronym OCTOPUS study
Serial number at source N/A
Study hypothesis Not provided at time of registration
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Sweden
Disease/condition/study domain Mild head injury
Participants - 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
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/05/2001
Anticipated end date 31/01/2004
Status of trial Completed
Patient information material
Target number of participants 2,500
Interventions 1. Admission for in-hospital observation
2. Urgent CT for all patients, early discharge if normal findings

Primary outcome measure(s) Study 1: Patient function at 3 months (Extended Glasgow Outcome Scale [GOSE]).
Study 2: Economic costs.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding All funding comes from public funds and peer-reviewed grants, including:
1. The Swedish Research Council
2. Expo/Stockholm County Council
3. The Vardal Foundation
4. The Health Research Council in the South-East of Sweden
5. Apoteket AB
6. The Swedish Society of Medicine
7. The Thelma Zoéga Foundation
8. Region Skåne
9. The Gorthon Foundation
Trial website
Publications 2006 results on medical outcome in http://www.ncbi.nlm.nih.gov/pubmed/16895944
2006 results on cost comparison in http://www.ncbi.nlm.nih.gov/pubmed/16895945
Contact name Dr  Jean-Luc  af Geijerstam
  Address Octopus Trial Co-ordinator
Karolinska Hospital
Institution of Medicine
Unit of Clinical Epidemiology
  City/town Stockholm
  Zip/Postcode SE-171 76
  Country Sweden
  Tel +46-8-517 797 05
  Fax +46-8-517 758 55
  Email octopus@medks.ki.se
Sponsor Institution of Medicine, Karolinska Hospital (Sweden)
  Address Unit of Clinical Epidemiology
  City/town Stockholm
  Zip/Postcode SE-171 76
  Country Sweden
  Tel +46-8-517 797 05
  Fax +46-8-517 758 55
  Email octopus@medks.ki.se
Date applied 27/08/2003
Last edited 25/09/2009
Date ISRCTN assigned 16/10/2003
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