Quantra QPlus Sample Type Comparison

• Sponsor: HemoSonics LLC (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05290675
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coagulation Defect; Bleeding	Diagnostic Test: Quantra QPlus System

Detailed Description

In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
• Actual Study Start Date: Nov 4, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Outcome Measures

Primary Outcome Measures

1. Comparison of QPlus Clot time (CT) in arterial and venous samples [During cardiac surgery]

   Coagulation function assessed in two sample types

2. Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples [During cardiac surgery]

   Coagulation function assessed in two sample types

3. Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples [During cardiac surgery]

   Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types

4. Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples [During cardiac surgery]

   Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types

5. Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples [During cardiac surgery]

   Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device

• Subject is ≥18 years

• Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.

Exclusion Criteria:

• Subject is younger than 18 years

• Subject is pregnant

• Subject is incarcerated at the time of the study

• Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks

• Subject, or subject's legally aurthorized representative is able to provide written 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: NCT05290675
• Other Study ID Numbers: HEMCS-042
• First Posted: Mar 22, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• 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: Cardiac surgery; Quantra; Viscoelastic testing; Coagulation
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Aug 10, 2022