NCT02978872

Brief Summary

The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

November 28, 2016

Last Update Submit

April 18, 2017

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryQuantraViscoelastic testingCoagulation

Outcome Measures

Primary Outcomes (1)

  • Comparison of Clot Time and Clot Stiffness results between arterial and venous samples

    Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)

    Up to 24 hours

Secondary Outcomes (2)

  • Comparison of Quantra results to standard coagulation test results in venous samples

    Up to 24 hours

  • Comparison of Quantra results to comparable ROTEM results in venous samples

    Up to 24 hours

Eligibility Criteria

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

Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device.

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 is willing to participate and he/she has signed a consent form
  • Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism 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

November 28, 2016

First Posted

December 1, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)