Procedure For The Reference Range Study For Absolute MA

NCT02110576 | Completed

• 1 other identifier: TP-CLN-100343
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transmission, Blood, Recipient/Donor

Outcome Measures

Primary Outcomes (1)

• TEG Reference Ranges

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

  Up to four months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haemonetics Corporation: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80203, United States

Location

Study Officials

• Ernest E. Moore, MD

  Denver Health Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-03

Locations

US (1)