Quantra QStat Sample Type Comparison

NCT ID: NCT06025708

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coagulation Defect; Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnostic Test: Quantra QStat Cartridge

Whole blood coagulation testing system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject is \>=18 years
* Subject is scheduled for liver transplant surgery
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent

Exclusion Criteria

* Subject is younger than 18 years of age
* Subject is pregnant
* Subject is incarcerated at the time of the study
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks
* Subject, or subject's LAR, is unable or unwilling to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEMCS-046

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.