NCT02978872

Completed

Quantra Determination of Coagulation Parameters in Arterial ...

HemoSonics LLC Source

Compare

Other study identifiers

Sponsor study identifier

HEMCS-005

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

July 2016

Actual (reported)

Primary Completion

January 2017

Actual (reported)

Study Completion

January 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: January 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2016
Actual (reported)
First Submitted
November 28, 2016
Actual (reported)
First Posted
December 1, 2016
Actual (reported)
Primary Completion
January 2017
Actual (reported)
Study Completion
January 2017
Actual (reported)

Last Updated: April 19, 2017
Status Verified: April 2017
Last Update Submitted: 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

Sponsors & Collaborators

HemoSonics LLC
Industrylead
University of Virginia
Othercollaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Enrollment

30 participants (actual enrollment reported by the registry).

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 2016

Actual (reported)

NCT03717649

Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)

Not ApplicableCompleted

NCT02712879

Moderate Bleeding in Cardiac Surgery Post Operative

Completed

NCT04654221

Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

Terminated

NCT02757118

Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery

Not ApplicableUnknown

NCT04373850

Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.

Not ApplicableCompleted

NCT02852889

Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery

Unknown

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.

Primary Completion

January 2017

Actual (reported)

Study Completion

January 2017

Actual (reported)

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02978872
Data provider: ClinicalTrials.gov
Source updated: 2017-04-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:12 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations