Transmission, Blood, Recipient/DonorNCT02110576
Procedure For The Reference Range Study For Absolute MA
An observational study of Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Transmission, Blood, Recipient/Donor
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80203
About this study
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.
Read the 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.
- Conditions
- Transmission, Blood, Recipient/Donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
TEG Reference Ranges
Reference ranges will be completed on 50 parameters sample type combinations for which 160 donors will be enrolled.
Measured: Up to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transmission, Blood, Recipient/DonorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ernest E. Moore, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110576
- Sponsor's protocol ID
- TP-CLN-100343
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedure For The Reference Range Study For Absolute MA
- ClinicalTrials.gov ID
- NCT02110576
- Acronym / sponsor ID
- TP-CLN-100343
- Conditions
- Transmission, Blood, Recipient/Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest E. Moore, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEG Reference Ranges (time frame: Up to four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.