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Thromboelastography (TEG) Reference Range Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haemonetics Corporation
ClinicalTrials.gov Identifier:
NCT01357928
First received: May 19, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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
Coagulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procedure for the Reference Range Study for Haemoscope Reagents

Further study details as provided by Haemonetics Corporation:

Enrollment: 159
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Volunteers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Haemonetics Corporation
ClinicalTrials.gov Identifier: NCT01357928     History of Changes
Other Study ID Numbers: TP-CLN-100048C
Study First Received: May 19, 2011
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Haemonetics Corporation:
TEG
Thromboelastography
Coagulation

ClinicalTrials.gov processed this record on November 27, 2014