Procedure For The Reference Range Study For Absolute MA

March 31, 2015 updated by: Haemonetics Corporation
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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80203
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Controls
Healthy controls 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ernest E. Moore, MD, Denver Health Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • TP-CLN-100343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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