Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000528550
Ethics application status
Approved
Date submitted
20/06/2006
Date registered
21/12/2006
Date last updated
21/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study is on haemoglobin accuracy, reliability and precision using the I-Stat point of care device.
Scientific title
Accuracy, precision and reliability of the I-Stat point of care device in assessment of haematocrit in patients undergoing massive blood loss and transfusion and with consequent instability of plasma albumin levels
Universal Trial Number (UTN)
Trial acronym
sharp
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Massive blood loss in surgery 1500 0
Condition category
Condition code
Surgery 1598 1598 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing two device measurements for haemoglobin, one is called the I-Stat machine and other device will be the standard method used in the laboratory. Three blood samples will be taken; one at baseline (induction of anaesthesia), second blood sample when 25% blood loss is achieved and a third blood sample if 40% blood loss is achieved. The samples would then be analysed by the laboratory (routinely) to determine haematocrit, and then also by the I-STAT to measure this same parameter. Simultaneously, we would measure plasma protein levels (in the laboratory (routinely) and with the I-Stat machine), and determine how the I-STAT measured haematocrit varies with these levels. Each I-STAT measurement would be duplicated in order to determine how the precision of the instrument varies with changing plasma protein levels.
Intervention code [1] 1151 0
Treatment: Devices
Comparator / control treatment
The standard method used in the laboratory.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2204 0
I-Stat Haemoglobin
Timepoint [1] 2204 0
Measured at start of surgery, 25 & 40% blood volume loss. The duplicated measurements are taken at the same time points; 25 & 40% blood loss.
Secondary outcome [1] 3845 0
Laboratory haemoglobin
Timepoint [1] 3845 0
Measured at start of surgery, 25 & 40% blood volume loss.
Secondary outcome [2] 3846 0
Laboratory and I-Stat plasma proteins
Timepoint [2] 3846 0
Measured at the following time points; induction of anaesthesia, when 25% blood loss is reached and when 40% blood loss is reached.
Secondary outcome [3] 3847 0
The duplicated I-Stat measurements
Timepoint [3] 3847 0
Taken at the same time points; when 25% blood loss is reached and when 40% blood loss is reached.

Eligibility
Key inclusion criteria
Surgery involving total blood loss of 25%.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) paitents with hypoalbuminaemia2) patients transfused with albumin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 358 0
New Zealand
State/province [1] 358 0

Funding & Sponsors
Funding source category [1] 1742 0
Hospital
Name [1] 1742 0
Auckland City Hospital
Country [1] 1742 0
New Zealand
Primary sponsor type
Individual
Name
Dr Wai Leap Ng
Address
Country
Secondary sponsor category [1] 1537 0
Individual
Name [1] 1537 0
Dr Kerry Gunn
Address [1] 1537 0
Country [1] 1537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3220 0
Auckland City Hospital
Ethics committee address [1] 3220 0
Ethics committee country [1] 3220 0
New Zealand
Date submitted for ethics approval [1] 3220 0
Approval date [1] 3220 0
02/05/2006
Ethics approval number [1] 3220 0
NTX/06/04/040

Summary
Brief summary
Patients having surgery that normally involves large blood-loss and volume replacement would be included in this study. The aim of the study is to demonstrate how changes in the composition of the circulating blood volume (plasma protein levels) affect the dependability of the haematocrit as measured by the i-STAT device. This device employs the analytical technique of conductometry to measure this variable, and conductometry is known to be affected by plasma protein levels. Blood samples would be drawn from the patient at various stages of the operation, after variable but recorded quantities of fluids had been given. These blood samples would have been collected for routine monitoring purposes. The samples would then be analysed by the laboratory (routinely) to determine haematocrit, and then also by the i-STAT to measure this same parameter. Hence, we can determine how these 2 measurements of the same parameter differ from one another. Simultaneously, we would measure plasma protein levels, and determine how the i-STAT-measured haematocrit varies with these levels. Finally, each i-STAT measurement would be duplicated in order to determine how the precision of the instrument varies with changing plasma protein levels. The only requirement of this study is to measure plasma protein levels in addition to the other routine tests of haematocrit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35412 0
Address 35412 0
Country 35412 0
Phone 35412 0
Fax 35412 0
Email 35412 0
Contact person for public queries
Name 10340 0
Dr Wai Leap Ng
Address 10340 0
Auckland City Hospital
Department of Anaesthesia
Level 8
Park Road
Grafton Auckland
Country 10340 0
New Zealand
Phone 10340 0
+64 21 868055
Fax 10340 0
+64 9 3754378
Email 10340 0
[email protected]
Contact person for scientific queries
Name 1268 0
Dr Kerry Gunn
Address 1268 0
Auckland City Hospital
Department of Anaesthesia
Level 8
Park Road
Grafton Auckland
Country 1268 0
New Zealand
Phone 1268 0
+64 27 427626
Fax 1268 0
+64 9 3754378
Email 1268 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.