Thromboelastography (TEG) Reference Range Study

Haemonetics

Status: Completed

Conditions: Coagulation

Study type: Observational

Funder types: Industry

Identifiers

NCT01357928

TP-CLN-100048C

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

159 participants in 1 patient group

Healthy Volunteers