Quantra QStat Sample Type Comparison

Coagulation Defect; Bleeding Clinical Trial

Official title:

Impact of Sample Type on the Performance of the Quantra QStat System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025708
• Other study ID #: HEMCS-046
• Status: Completed
• Start date: September 11, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 1, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemostatic Disorders

Intervention

Device:
• Diagnostic Test: Quantra QStat Cartridge
Whole blood coagulation testing system

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of QStat Clot time (CT) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Primary	Comparison of QStat Clot stiffness (CS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Primary	Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Primary	Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Primary	Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery