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An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge

NCT06352125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 338

Last updated 2024-04-08

No results posted yet for this study

Summary

This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.

Conditions

  • Surgery

Interventions

DIAGNOSTIC_TEST

TEG 6s Citrated K, KH, RTH, 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

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

  • ClinStatDevice

    collaborator UNKNOWN

  • Boston Healthcare Technologies Consultants, LLC

    collaborator UNKNOWN

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Jan Hartmann, MD · Haemonetics Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2023-01-31
Completion
2023-01-31
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 NCT06352125 on ClinicalTrials.gov