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Thromboelastography (TEG) Reference Range Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357928
First Posted: May 23, 2011
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haemonetics Corporation
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
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
  More Information

Responsible Party: Haemonetics Corporation
ClinicalTrials.gov Identifier: NCT01357928     History of Changes
Other Study ID Numbers: TP-CLN-100048C
First Submitted: May 19, 2011
First Posted: May 23, 2011
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Haemonetics Corporation:
TEG
Thromboelastography
Coagulation