NCT05290675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

January 13, 2022

Last Update Submit

April 28, 2023

Conditions

Coagulation Defect; Bleeding

Keywords

Cardiac surgeryQuantraViscoelastic testingCoagulation

Outcome Measures

Primary Outcomes (5)

  • Comparison of QPlus Clot time (CT) in arterial and venous samples

    Coagulation function assessed in two sample types

    During cardiac surgery

  • Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples

    Coagulation function assessed in two sample types

    During cardiac surgery

  • Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples

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

    During cardiac surgery

  • Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples

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

    During cardiac surgery

  • Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples

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

    During cardiac surgery

Interventions

Quantra QPlus SystemDIAGNOSTIC_TEST

Whole blood coagulation testing system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult males and females undergoing cardiac surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hemostatic DisordersHemorrhageThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

March 22, 2022

Study Start

November 4, 2021

Primary Completion

August 31, 2022

Study Completion

November 2, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)