Quantra QStat Sample Type Comparison

• Sponsor: HemoSonics LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06025708
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 4.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coagulation Defect; Bleeding	Device: Diagnostic Test: Quantra QStat Cartridge

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 Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Sample Type on the Performance of the Quantra QStat System
• Anticipated Study Start Date: Sep 5, 2023
• Anticipated Primary Completion Date: Nov 20, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Outcome Measures

Primary Outcome Measures

1. Comparison of QStat Clot time (CT) in arterial and venous samples [During liver transplantation surgery]

   Coagulation function assessed in two sample types

2. Comparison of QStat Clot stiffness (CS) in arterial and venous samples [During liver transplantation surgery]

   Coagulation function assessed in two sample types

3. 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

4. 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

5. Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples [During liver transplantation surgery]

   Coagulation function assessed in two sample types

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• HemoSonics LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HemoSonics LLC
• ClinicalTrials.gov Identifier: NCT06025708
• Other Study ID Numbers: HEMCS-046
• First Posted: Sep 6, 2023
• Last Update Posted: Sep 6, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by HemoSonics LLC: Quantra; Liver transplantation; Coagulation
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Sep 6, 2023