None listed
Conditions
Brief summary
Thromboelastography (TEG) allows rapid, comprehensive and accurate identification of an individual’s haemostasis condition in a laboratory or point-of-care setting. Until now, different TEG assays had to be performed individually, with each assay requiring lengthy preparation and calibrated pipetting. TEG6s and TEG5000 (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers. After Ethics Committee approval, we systematically collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). A trained operator, proficient in the use of both the TEG6S and TEG5000 systems performed all the measurements. Interdevice agreement between the TEG6S and TEG5000 analysers was measured using Lin’s condordance coefficient, and further validated this using intraclass correlation coefficients and reduced major axis regression, which allowed separation of the observed bias into fixed and proportional components. As this is an observational device study, no results results will be used by any clinician to influence patient care.
Interventions
This is an observation study. No results will be used by any clinician to influence patient care.
TEG6s (Registered) and TEG5000 (Registered) (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this observational study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers.
A trained operator, proficient
This is an observation study. No results will be used by any clinician to influence patient care. TEG6s (Registered) and TEG5000 (Registered) (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this observational study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers. A trained operator, proficient in the use of both the TEG6s and TEG5000 systems will perform all the measurements. The skilled operator will collect 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit. Measurements will be performed by one operator on two TEG devices i.e. (“Interdevice” agreement). Five variables will be examined on each device. Agreement between these variables will be compared. The variables to measured include: 1. Reaction Time (R) measured in minutes 2. Kinetics Time (K) measured in minutes 3. Alpha Angle (AA) measured in degrees 4. Maximum Amplitude (MA), measured in millimetres 5. Lysis 30 (LY30), measured as a percentage (%) Duration of follow up will be until each test has been completed. This takes approximately 60 minutes. There is no patient follow up as this study is device validation study.
Sponsors
Austin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients admitted to ICU who required an arterial line as part of standard care. Patients admitted to ICU who receive TEG as part of standard routine hospital care. Patients undergoing major cardiac surgery who receive TEG as part of standard routine hospital care. Adult patients (Age 18 years or greater)
Exclusion criteria
Subjects less than 18 years old. Subjects who would not otherwise require TEG assessment as part of their standard clinical care.
Outcome results
None listed