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Completed

NCT Number: NCT06261580

Normal Reference Range Study With the TEG6s 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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Machaon Diagnostics, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult volunteers (18 years of age and older) who self-identify as being in general good health.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

TEG 6s Citrated K, KH, RTH, and FFH Cartridge

Diagnostic 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 Fibrinogen

Diagnostic 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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Collaborators

  • ClinStatDevice
  • Machaon Diagnostics

Registry information

Official study title

Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

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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