Thromboelastography (TEG) Reference Range Study

Completed

• Conditions: Coagulation

• Registration Number: NCT01357928
• Lead Sponsor: Haemonetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

North Shore-Long Island Jewish Health System; 🇺🇸 Manhasset, New York, United States