Agreement and clinical interchangeability of a coagulation monitoring analyser between devices, operators, and across multiple time points.

Agreement and clinical interchangeability of the TEG6S (Registered) haemostatic analyser between devices, operators, and across multiple time points: a comprehensive prospective validation study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616001698460

Acronym

Non applicable

Enrollment

Registered

2016-12-09

Start date

2015-04-09

Completion date

2015-09-12

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

TEG6S (Haemonetics Corp, USA) is a novel haemostasis analyser that measures viscoelasticity properties of blood using resonance technology. We assessed agreement of the TEG6S analyser between devices, operators, and across multiple time points. We collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). Measurements were performed by one operator on two TEG6S devices (“Interdevice” agreement). Then, 5 different operators performed sample analysis from 5 healthy volunteers, using 5 TEG6S devices (“Interoperator” agreement). Finally, a single operator performed 15 measurements on 4 TEG6S devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) was examined. “Interdevice” agreement was estimated using Lin’s condordance coefficient and further validated using intraclass correlation coefficients and reduced major axis regression. “Interoperator” and “Timepoint” agreement was assessed using the Intraclass correlation coefficient estimated by a random effect regression model.

Interventions

This study is an observational study to test “Interdevice” agreement", “Interoperator” agreement" and "time point agreement" using the TEG6S (Registered) device. No results results will be used by any clinician to influence patient care. Skilled operators of the TEG6S (Registered) device 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 TEG6S (Registered) devices i.e. (“Interdevice” agreement). Then, 5 different skilled operators will perform sample analyses from 5 healthy volunteers, perform measurements using 5 TEG6S (Registered) devices i.e. (“Interoperator” agreement). Finally, a single operator will perform 15 measurements on 4 TEG6S (Registered) devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) will be examined. 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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Patients admitted to ICU who required an arterial line as part of standard care. 2. Patients admitted to ICU who receive TEG as part of standard routine hospital care. 3. Patients undergoing major cardiac surgery who receive TEG as part of standard routine hospital care. 4. Age >18 years. 5. Healthy volunteers.

Exclusion criteria

1. Subjects who were less than 18 years old. 2. Subjects who would not otherwise require TEG assessment as part of their standard clinical care. 3. Healthy volunteers with any chronic medical condition or complex comorbidity 4. Healthy volunteers on any regular medication, including the oral contraceptive pill

Outcome results