Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
07/03/2008
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 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 measures

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

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

http://www.erasmusmc.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes