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Study is on haemoglobin accuracy, reliability and precision using the I-Stat point of care device.

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000528550
Acronym
sharp
Enrollment
30
Registered
2006-12-21
Start date
2006-07-03
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 t

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.

Sponsors

Dr Wai Leap Ng
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Surgery involving total blood loss of 25%.

Exclusion criteria

1) paitents with hypoalbuminaemia2) patients transfused with albumin.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026