NCT01357928

Thromboelastography (TEG) Reference Range Study

Procedure for the Reference Range Study for Haemoscope Reagents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 159 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coagulation

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2011-05-23
• Last updated: 2012-09-05

Locations

1 site across 1 country: United States