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Completed

NCT Number: NCT02110576

Procedure For The Reference Range Study For Absolute MA

CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty normal donors to create reference intervals for various Haemonetics reagents. Venous blood from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be drawn at the study site to account for aberrant or outlying data excluded for technical or other reasons.

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Key information

Conditions

Transmission, Blood, Recipient/Donor

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health Medical Center

Denver, Colorado, 80203, United States

About this study

As part of an examination of how LY30 is calculated, the investigators would like to explore the differences between Maximum Amplitude (MA) and LY30 calculated in the traditional small deviation method and by an absolute MA method.

The maximum amplitude (MA) for a sample is determined in real-time using one of two MA-identifying algorithms: Small Deviation MA (the default algorithm) or Absolute MA. Both algorithms are available in commercially available software. Both algorithms find an MA for a sample; however, the difference between the two algorithms is the "acceptance criteria" which each use for identifying the MA. As compared to Small Deviation MA, the Absolute MA has a larger and more stringent rules set.

A study will be run to establish reference intervals 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. To meet the guidance outlined in the CLSI guideline, we will collect a minimum of 146 donors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female over the age of 18 years.
  • Self-identified as being in general good health, without chronic disease/illness, including but not limited to: cancer, diabetes mellitus, renal disease, cardiac disease, hypertension, lung disease, liver disease, complications of morbid obesity, autoimmune/inflammatory disease, or any condition of sufficient severity that it requires daily medication to manage

Exclusion criteria

  • Age < 18 years.
  • Infusion of blood products prior to the collection of blood samples.
  • Known or subsequently discovered inherited defects of coagulation function (e.g. hemophilia or Von Willebrand's disease).
  • Those females known to be pregnant
  • Anticoagulant, antiplatelet, hormone or hormonal contraceptive therapy including aspirin use within the past month or NSAID use within the past week
  • Surgery or traumatic injury within the previous 6 weeks
  • Bruising, wounds or scarring in the area of venipuncture on the upper extremities

Treatment and study plan

Primary outcomes

  1. TEG Reference Ranges

    Time frame: Up to four months

    Reference ranges will be completed on 50 parameters sample type combinations for which 160 donors will be enrolled.

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 10, 2014
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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