HealthyNCT06261580
Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers
An observational study of Healthy, run by Haemonetics Corporation at 3 sites in United States.
Trial summary
This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range. Written consent to participate in the study will be obtained prior to volunteer screening per site procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TEG 6s Citrated K, KH, RTH, and FFH Cartridge and Clauss Fibrinogen
- How many people
- 181 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jul 2021to 25 Oct 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Healthy Volunteers
Who may be able to join
- Adult volunteers (18 years of age and older) who self-identify as being in general good health.
Who cannot join
- Volunteers with any acute illness or uncontrolled chronic disease
- Volunteers with any type of cancer
- Volunteers with diabetes
- Volunteers with renal disease
- Volunteers with liver disease
- Volunteers with morbid obesity
Show all 21Show fewer
- Volunteers with autoimmune or inflammatory diseases
- Volunteers with known coagulation and/or bleeding disorders (e.g., hemophilia, Von Willebrand's disease)
- Volunteers currently abusing alcohol (defined as more than 3 drinks for women and more than 4 drinks for men on any given day, or 7 drinks for women and 14 drinks for men throughout the week) or taking illicit drugs
- Volunteers with hereditary fibrinolytic bleeding disorders
- Volunteers with altered coagulation due to the presence of direct oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran) in the blood
- Volunteers on any fibrinolytic activators (e.g., Streptokinase, t-PA, Reteplase, Tenecteplase, Urokinase, APSAC, Staphylokinase)
- Volunteers who have had recent surgery (within the last four weeks)
- Volunteers with any injuries leading to substantial bleeding or bruising (within the last two weeks prior to blood donation)
- Volunteers with bruising, wounds, or scarring around the selected venipuncture site
- Volunteers deemed unfit for participation in the trial by the principal investigator
- Volunteers participating in another clinical trial that would not be scientifically or medically compatible with this trial
- Volunteers who have been on P2Y12 inhibitors within the last 30 days
- Volunteers receiving treatment with low molecular weight heparin (e.g., enoxaparin)
- Volunteers with altered coagulation due to the presence of drugs known to affect the coagulation status in the blood (see Table 1)
- Volunteers who have participated in this trial previously
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cardiovascular Research Institute - Loyola University Chicago Health Sciences
Maywood, Illinois, 60153
Louisiana Coagulation / Machaon Division
New Orleans, Louisiana, 70118
Machaon Diagnostics
Oakland, California, 94609
About this study
Official title: Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers
This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.
Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.
- Conditions
- Healthy
- Being tested
- TEG 6s Citrated K, KH, RTH, and FFH Cartridge, Clauss Fibrinogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG 6s Citrated K, KH, RTH, and FFH CartridgeDiagnostic test
The TEG® 6s uses the Global Hemostasis with Heparin Neutralization (HN) Cartridge to test the hemostasis properties of citrated blood samples using four different assays/reagents simultaneously, one in each of the four cartridge channels.
Clauss FibrinogenDiagnostic test
Fibrinogen, also known as Factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot"). Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains. The biological half-life of plasma fibrinogen is 3 to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Adult volunteers (18 years of age and older) who self-identify as being in general good health. Receives: Diagnostic Test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge; Diagnostic Test: Clauss Fibrinogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
CK-MA TEG Parameter
Citrated Kaolin Maximum Amplitude Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CK-R TEG Parameter
Citrated Kaolin Reaction Time Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
CKH-MA TEG Parameter
Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CKH-R TEG Parameter
Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
CKH-LY30 TEG Parameter
Citrated Kaolin with Heparinase Lysis Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
CRTH-MA TEG Parameter
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
CFFH-MA TEG Parameter
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start28 Jul 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Machaon Diagnostics, ClinStatDevice
- Responsible party
- Sponsor
- Investigators
- Yamini Bynagari, PhD, Principal investigator, Machaon Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261580
- Sponsor's protocol ID
- TP-CLN-100502
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06261580
- Acronym / sponsor ID
- TP-CLN-100502
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Machaon Diagnostics, ClinStatDevice
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 15 Feb 2024 (actual)
- 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.
This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.
Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Diagnostic Test: TEG 6s Citrated K, KH, RTH, and FFH Cartridge, Diagnostic Test: Clauss FibrinogenAdult volunteers (18 years of age and older) who self-identify as being in general good health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Healthy Volunteers
Key inclusion criteria (1 listed)
- Adult volunteers (18 years of age and older) who self-identify as being in general good health.
Key exclusion criteria (21 listed)
- Volunteers with any acute illness or uncontrolled chronic disease
- Volunteers with any type of cancer
- Volunteers with diabetes
- Volunteers with renal disease
- Volunteers with liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEG 6s Citrated K, KH, RTH, and FFH CartridgeThe TEG® 6s uses the Global Hemostasis with Heparin Neutralization (HN) Cartridge to test the hemostasis properties of citrated blood samples using four different assays/reagents simultaneously, one in each of the four cartridge channels. | Diagnostic test | Healthy Volunteers |
| Clauss FibrinogenFibrinogen, also known as Factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot"). Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains. The biological half-life of plasma fibrinogen is 3 to 5 days. | Diagnostic test | Healthy Volunteers |
Primary outcome
CK-MA TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Kaolin Maximum Amplitude Thromboelastographic Result
CK-R TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Citrated Kaolin Reaction Time Thromboelastographic Result
CKH-MA TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result
CKH-R TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result
CKH-LY30 TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
Citrated Kaolin with Heparinase Lysis Thromboelastographic Result
CRTH-MA TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
CFFH-MA TEG Parameter
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
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 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Yamini Bynagari, PhD principal investigator
Machaon Diagnostics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Haemonetics Corporation at 3 sites 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 1 inclusion and 21 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
CK-MA TEG Parameter (time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.). The study lists 7 primary outcomes in all. 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 15 Feb 2024.