Thromboelastography (TEG) Reference Range Study
This study has been completed.
Information provided by (Responsible Party):
First received: May 19, 2011
Last updated: September 4, 2012
Last verified: September 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Procedure for the Reference Range Study for Haemoscope Reagents
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or Female over the age of 18 years.
- 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)
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
|North Shore-Long Island Jewish Health System
|Manhasset, New York, United States, 11030 |
||William A Heaton, M.D.
||NSLIJ Health System
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 19, 2011
||September 4, 2012
||United States: Institutional Review Board
Keywords provided by Haemonetics Corporation:
ClinicalTrials.gov processed this record on March 30, 2015