Use of the Quantra QPlus Sytem in Cardiac Surgery

August 12, 2022 updated by: HemoSonics LLC

Utilization of the Quantra QPlus System to Guide the Management of Blood Product Transfusions in Cardiac Surgery Patients: Effects on Clinical and Economic Outcomes

Single center retrospective study evaluating the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Yavapai Regional Medical Center (YRMC) implemented the Quantra QPlus System to aid in their efforts to effectively reduce the transfusion rate of allogenic blood products and improve outcomes in patients undergoing cardiac surgery. Use of the Quantra to guide decisions related to the use of blood products in cardiac surgery patients began in 2019. In this retrospective study, YRMC evaluated the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Prescott, Arizona, United States, 86301
        • Yavapai Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiac surgery performed by the same surgical team.

Description

  • Pre-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from January 2019 to September 2019 (n=64)
  • Post-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from May 2020 to April 2021 (n=64)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Quantra
Patients undergoing cardiac surgery prior to the introduction of the Quantra.
Post-Quantra
Patients undergoing cardiac surgery after the introduction of the Quantra.
Diagnostic test: Quantra QPlus System
Coagulation monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood product utilization
Time Frame: Intraoperative - during surgery
Units of blood products administered to patient
Intraoperative - during surgery
Blood product utilization
Time Frame: Postoperative - after surgery throughout the rest of the hospital stay, assessed up to 30 days
Units of blood products administered to patient
Postoperative - after surgery throughout the rest of the hospital stay, assessed up to 30 days
Cost of blood products
Time Frame: Throughout the entire hospital stay, assessed up to 30 days
Total cost of blood products administered to patient
Throughout the entire hospital stay, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemoSonics LLC

Investigators

  • Principal Investigator: Pierre Tibi, MD, Yavapai Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

November 21, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMCS-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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