Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/08/2003
Date assigned
16/10/2003
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Luc af Geijerstam

ORCID ID

Contact details

Octopus Trial Co-ordinator
Karolinska Hospital
Institution of Medicine
Unit of Clinical Epidemiology
Stockholm
SE-171 76
Sweden
+46-8-517 797 05
octopus@medks.ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

OCTOPUS study

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mild head injury

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2001

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

2,500

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2001

Recruitment end date

31/01/2004

Locations

Countries of recruitment

Sweden

Trial participating centre

Octopus Trial Co-ordinator
Stockholm
SE-171 76
Sweden

Sponsor information

Organisation

Institution of Medicine, Karolinska Hospital (Sweden)

Sponsor details

Unit of Clinical Epidemiology
Stockholm
SE-171 76
Sweden
+46-8-517 797 05
octopus@medks.ki.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Expo/Stockholm County Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Vardal Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Health Research Council in the South-East of Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Apoteket AB

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Society of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Thelma Zoéga Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Skåne

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Gorthon Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results on medical outcome

    af Geijerstam JL, Oredsson S, Britton M, , Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial., BMJ, 2006, 333, 7566, 465, doi: 10.1136/bmj.38918.669317.4F.

  2. Results on cost comparison

    Norlund A, Marké LA, af Geijerstam JL, Oredsson S, Britton M, , Immediate computed tomography or admission for observation after mild head injury: cost comparison in randomised controlled trial., BMJ, 2006, 333, 7566, 469, doi: 10.1136/bmj.38918.659120.4F.

Additional files

Editorial Notes