Thromboelastography (TEG) Reference Range Study

Completed

Conditions studied: Coagulation

In brief

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.

Key facts

Study ID

NCT01357928

Run by

Haemonetics Corporation

People needed

159

Starts

2011-04-01

Expected to finish

2011-10-01

Last updated by the study team

2012-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or Female over the age of 18 years.

You may not qualify if…

• 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)

Where it is running

• North Shore-Long Island Jewish Health System — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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