Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000143527
Ethics application status
Approved
Date submitted
21/04/2006
Date registered
27/04/2006
Date last updated
5/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
MINIMI Study
Scientific title
MINIMI Multi-centre study. Minimising blood loss during blood testing from intra-arterial catheters in intensive care patients
Universal Trial Number (UTN)
Trial acronym
MINIMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care patients requiring blood tests from an intra-arterial catheter 1112 0
Condition category
Condition code
Anaesthesiology 1192 1192 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomised crossover trial. Patients are randomised to a sequence of blood tests which are taken sequentially. The intervention is the size of discard volume (blood discarded to clear the line). This is calculated as a multiple of the deadspace in the system prior to blood sampling. Six discard volumes will be tested. Each patient acts as their own control and receives each of the experiemental discard volumes. Duration: The blood sampling for the study is done on one occasion with 48 sequential blood tests (6 each of full blood count, creatinine & electrolytes, liver functions, coagulation, magnesium, troponin, calcium, & phosphate. The process will be completed within 10 minutes. Timepoint: At some stage of the intensive care admission when the patient meets the study criteria and samples can be obtained without disrupting clinical care.
Intervention code [1] 991 0
Other interventions
Comparator / control treatment
patient is own control, different discard volumes are used for each set of blood tests
Control group
Active

Outcomes
Primary outcome [1] 1606 0
Accuracy of full blood count
Timepoint [1] 1606 0
immediately after blood sampling
Primary outcome [2] 1607 0
Accuracy of creatine and electrolytes
Timepoint [2] 1607 0
immediately after blood sampling
Primary outcome [3] 1608 0
immediately after blood sampling
Timepoint [3] 1608 0
immediately after blood sampling
Primary outcome [4] 1609 0
Accuracy of coagulation studies
Timepoint [4] 1609 0
immediately after blood sampling
Primary outcome [5] 1610 0
Accuracy of magnesium, phosphate and calcium
Timepoint [5] 1610 0
immediately after blood sampling
Primary outcome [6] 1611 0
Accuracy of troponin
Timepoint [6] 1611 0
immediately after blood sampling
Secondary outcome [1] 2907 0
Develop model to minimise blood loss in ICU patients from diagnostic testing.
Timepoint [1] 2907 0
This will be done during the data analysis phase.

Eligibility
Key inclusion criteria
Informed written consent from patient or legal representative• Patent arterial catheter in situ as part of routine care • Haemoglobin >8.0g/dL• Clinically stable (has neither required nor is anticipated to require any intervention in the 30 minutes prior to, or during the sampling period).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current bleeding or major surgery planned in the next 48 hours• Current transfusion of blood products, hypertonic electrolytes, or anticoagulants other than heparin saline in flush devices• Patient with extracorporeal circuits• Non-English speaking patient or legal representative• Patient not expected to survive the next 24 hours or patient/relatives deemed too emotionally distressed to be approached• Inotrope support exceeding Nor-Adrenaline and Adrenaline > 5mcg/min, Dopamine and Dobutamine > 5mcg/kg/min.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Dummy times recorded on pathology forms
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1303 0
Hospital
Name [1] 1303 0
ICU Departments of Launceston General Hospital
Country [1] 1303 0
Australia
Funding source category [2] 1304 0
Hospital
Name [2] 1304 0
Royal Prince Alfred Hospital
Country [2] 1304 0
Australia
Funding source category [3] 1305 0
Hospital
Name [3] 1305 0
Sir Charles Gairdner Hospital
Country [3] 1305 0
Australia
Funding source category [4] 1306 0
University
Name [4] 1306 0
Uni of Tasmania School of Nursing and Midwifery
Country [4] 1306 0
Australia
Funding source category [5] 3680 0
Charities/Societies/Foundations
Name [5] 3680 0
Clifford Craig Medical Research Trust
Country [5] 3680 0
Australia
Funding source category [6] 3681 0
University
Name [6] 3681 0
Griffith University
Country [6] 3681 0
Australia
Primary sponsor type
University
Name
Griffith University School of Nursing and Midwifery
Address
School of Nursing and Midwifery
Griffith University Nathan Campus Kessels Rd Nathan QLD 4111
Newnham Campus
Country
Australia
Secondary sponsor category [1] 1151 0
Hospital
Name [1] 1151 0
Launceston General Hospital
Address [1] 1151 0
Charles St Launceston TAS 7250
Country [1] 1151 0
Australia
Secondary sponsor category [2] 1152 0
Hospital
Name [2] 1152 0
ICU Departents:Royal Prince Alfred Hospital
Address [2] 1152 0
Sydney NSW
Country [2] 1152 0
Australia
Secondary sponsor category [3] 1153 0
Hospital
Name [3] 1153 0
ICU Departents: Sir Charles Gairdner Hospital
Address [3] 1153 0
Nedlands WA
Country [3] 1153 0
Australia
Secondary sponsor category [4] 3305 0
Charities/Societies/Foundations
Name [4] 3305 0
Clifford Craig Medical Research Trust Fund
Address [4] 3305 0
PO Box 1963 Launceston TAS 7250.
Country [4] 3305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2632 0
Tasmanian State Health Research Ethics Committee
Ethics committee address [1] 2632 0
University of Tasmania
Sandy Bay Campus Hobart Tas
Ethics committee country [1] 2632 0
Australia
Date submitted for ethics approval [1] 2632 0
Approval date [1] 2632 0
20/02/2006
Ethics approval number [1] 2632 0
H0008638.
Ethics committee name [2] 2633 0
Royal Prince Alfred Hospital
Ethics committee address [2] 2633 0
Sydney NSW
Ethics committee country [2] 2633 0
Australia
Date submitted for ethics approval [2] 2633 0
Approval date [2] 2633 0
07/12/2005
Ethics approval number [2] 2633 0
X05-0354
Ethics committee name [3] 2634 0
Sir Charles Gairdner Hospital
Ethics committee address [3] 2634 0
Hospital Drive Nedlands, WA
Ethics committee country [3] 2634 0
Australia
Date submitted for ethics approval [3] 2634 0
Approval date [3] 2634 0
16/03/2006
Ethics approval number [3] 2634 0
2006-001

Summary
Brief summary
Intensive care patients require many blood tests. Each blood test requires a small amount of blood loss and when added together this can lead to anaemia and the need for a blood transfusion. ICU blood tests are taken through a drip, and an amount of blood must be wasted each time, to clear the drip set and access the patient’s blood. This “discard volume” is important: too little and the blood tests may be inaccurate, too much and the patient loses even more blood unnecessarily. The ideal discard volume for most blood tests is unknown and so hospitals and health professionals take various amounts; it is highly likely that unnecessary blood loss occurs.

In our study we plan to identify the minimum discard volume required to obtain accurate results for several of the most common blood tests performed in ICUs. The laboratory scientists (assessors) performing the outcomes measures will be blinded to intervention group of each blood sample.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36155 0
Address 36155 0
Country 36155 0
Phone 36155 0
Fax 36155 0
Email 36155 0
Contact person for public queries
Name 10180 0
Prof Claire Rickard
Address 10180 0
Research Centre for Clinical and Community Practice Innovation
Griffith University, Nathan Campus, QLD
Country 10180 0
Australia
Phone 10180 0
61 7 3735 6460
Fax 10180 0
Email 10180 0
[email protected]
Contact person for scientific queries
Name 1108 0
Prof Claire Rickard
Address 1108 0
Research Centre for Clinical and Community Practice Innovation
Griffith University
Nathan Campus QLD 4111
Country 1108 0
Australia
Phone 1108 0
61 7 3735 6460
Fax 1108 0
Email 1108 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.