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Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers

NCT06261580 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 181

Last updated 2024-02-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIAGNOSTIC_TEST

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

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.

DIAGNOSTIC_TEST

Clauss Fibrinogen

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.

Sponsors & Collaborators

  • Machaon Diagnostics

    collaborator INDUSTRY

  • ClinStatDevice

    collaborator UNKNOWN

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Yamini Bynagari, PhD · Machaon Diagnostics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2021-10-25
Completion
2021-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261580 on ClinicalTrials.gov