NCT03931031

Brief Summary

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

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

March 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

April 20, 2019

Last Update Submit

June 30, 2020

Conditions

Blood Loss, Surgical

Keywords

Viscoelastic testingCoagulationQuantraHemostasis

Outcome Measures

Primary Outcomes (8)

  • Comparison of Quantra Clot Time test results to TEG test results.

    Coagulation function assessed by Quantra and TEG.

    Prior to surgery (Baseline)

  • Comparison of Quantra Clot Stiffness test results to TEG test results.

    Coagulation function assessed by Quantra and TEG.

    Prior to surgery (Baseline)

  • Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.

    Coagulation function assessed by Quantra and TEG.

    Post-bypass (10 to 20 minutes after protamine administration).

  • Comparison of Quantra Clot Time test results to TEG test results.

    Coagulation function assessed by Quantra and TEG.

    Post-bypass (10 to 20 minutes after protamine administration).

  • Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen

    Coagulation function assessed by Quantra and laboratory fibrinogen testing

    Prior to surgery (Baseline)

  • Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen

    Coagulation function assessed by Quantra and laboratory fibrinogen testing

    Post-bypass (10 to 20 minutes after protamine administration).

  • Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count

    Coagulation function assessed by Quantra and laboratory fibrinogen testing

    Post-bypass (10 to 20 minutes after protamine administration).

  • Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count

    Coagulation function assessed by Quantra and platelet count

    Prior to surgery (Baseline)

Study Arms (1)

Cardiac Surgery Patients

Patients taking antiplatelet medication who are scheduled for elective cardiac surgery.

Diagnostic Test: Quantra System

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Also known as: Quantra QPlus Cartridge
Cardiac Surgery Patients

Eligibility Criteria

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

Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.

You may qualify if:

  • Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
  • Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
  • Subject is ≥ 18 years
  • Subject is willing to participate and he/she has signed a consent form

You may not qualify if:

  • Subject is younger that 18 years
  • Subject is unable to provide written informed consent
  • Subject is incarcerated at the time of the study
  • Subject is pregnant
  • Subject is currently enrolled in a distinct study that might confound the results of the proposed study
  • Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

MeSH Terms

Conditions

Blood Loss, SurgicalThrombosis

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

April 20, 2019

First Posted

April 29, 2019

Study Start

March 21, 2019

Primary Completion

April 7, 2020

Study Completion

June 27, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)