Contact information
Type
Scientific
Primary contact
Dr I B Schipper
ORCID ID
Contact details
Erasmus Medical Center
Trauma Center ZWN
Room Z-9.15
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5034
i.schipper@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
AIOD
Study hypothesis
The aim of this study is to analyse whether or not it is possible to created a fast, reliable intraosseous entrance using the BIG and/or FAST bone needles, with less complications compared with the traditional bone needle Jamshidi.
Ethics approval
Approval received from the Medical Ethical review board, Erasmus Medical Centre, Rotterdam, The Netherlands. The approval was completed at 15th June 2006 with reference number MEC-2006-109.
Study design
Randomised, controlled, parallel group, single blinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe injury, life threatening
Intervention
The intervention consists of the application of a randomised instraosseous needle:
1. In people over 14 years: BIG versus FAST versus conventional bone needle
2. In children more than one and less than 14 years: BIG versus conventional bone needle
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
1. Primary endpoint: aspiration of bone marrow upon successful placement of a bone needle.
2. Primary parameter is time required for successful placement.
Secondary outcome measures
Secondary endpoint: Complications encoured using an intraosseous device
Secondary parameters:
1. Adverse events
2. Success rate (%)
3. User friendliness (Visual Analogue Scale [VAS])
4. Pain scored by the patient (VAS)
Overall trial start date
21/06/2006
Overall trial end date
20/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients in acute life threatening situations, requiring assistance of a mobile medical team
2. Intravascular medical or fluid resuscitation is necessary and intravascular access cannot be obtained after two attempts
Participant type
Patient
Age group
Other
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
1. Children under the age of one year
2. Patients with suspected sternumanomaly (only FAST1)
Recruitment start date
21/06/2006
Recruitment end date
20/06/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
Trauma Center ZWN
P.O. Box 2040
Amsterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Medirisk (The Netherlands)
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
Basic results (scientific)
Publication list