Quantra QStat Sample Type Comparison

Completed

• Conditions: Coagulation Defect; Bleeding

• Registration Number: NCT06025708
• Lead Sponsor: HemoSonics LLC

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Study Start: 2023-09-11
• Primary Completion: 2024-01-05
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of QStat Clot time (CT) in arterial and venous samples	During liver transplantation surgery	Coagulation function assessed in two sample types
Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples	During liver transplantation surgery	Coagulation function assessed in two sample types
Comparison of QStat Clot stiffness (CS) in arterial and venous samples	During liver transplantation surgery	Coagulation function assessed in two sample types
Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples	During liver transplantation surgery	Coagulation function assessed in two sample types
Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples	During liver transplantation surgery	Coagulation function assessed in two sample types

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States