Thromboelastography (TEG) Reference Range Study

Coagulation Clinical Trial

Official title:

Procedure for the Reference Range Study for Haemoscope Reagents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357928
• Other study ID #: TP-CLN-100048C
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: September 4, 2012
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: September 2012
• Source: Haemonetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coagulation

Locations

Country	Name	City	State
United States	North Shore-Long Island Jewish Health System	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Haemonetics Corporation

Country where clinical trial is conducted

United States,