Thromboelastography (TEG) Reference Range Study

Procedure for the Reference Range Study for Haemoscope Reagents

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01357928

Enrollment

159

Registered

2011-05-23

Start date

2011-04-30

Completion date

2011-10-31

Last updated

2012-09-05

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

Conditions

Coagulation

Keywords

TEG, Thromboelastography, Coagulation

Brief summary

As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or Female over the age of 18 years.

Exclusion criteria

* Genetic bleeding disorders * Currently Pregnant * Oral Contraceptives * On anti-coagulants or anti-platelet therapy * Took ASA (Acetylsalicylic Acid)within 1 week prior * Recent surgery (within 4 weeks) * Recent injury leading to substantial bruising (within 2 weeks)

Countries

United States

Outcome results