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Thromboelastography (TEG) Reference Range Study

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ClinicalTrials.gov Identifier: NCT01357928
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Coagulation

Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procedure for the Reference Range Study for Haemoscope Reagents
Study Start Date : April 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Group/Cohort
Healthy Volunteers




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357928


Locations
United States, New York
North Shore-Long Island Jewish Health System
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Haemonetics Corporation
Investigators
Principal Investigator: William A Heaton, M.D. NSLIJ Health System

Responsible Party: Haemonetics Corporation
ClinicalTrials.gov Identifier: NCT01357928     History of Changes
Other Study ID Numbers: TP-CLN-100048C
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Haemonetics Corporation:
TEG
Thromboelastography
Coagulation