Thromboelastography (TEG) Reference Range Study

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.

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Key information

Conditions

Coagulation Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Shore-Long Island Jewish Health System

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Registry information

Official study title

Procedure for the Reference Range Study for Haemoscope Reagents

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 23, 2011
Registry last updated: Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed