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NCT05501730 Clinical Trial

Use of the Quantra QPlus Sytem in Cardiac Surgery

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05501730
Other study ID # HEMCS-038
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date December 15, 2021

Study information
Verified date August 2022
Source HemoSonics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date December 15, 2021
Est. primary completion date November 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Quantra QPlus System
Coagulation monitoring system

Locations
Country Name City State
United States Yavapai Regional Medical Center Prescott Arizona

Sponsors (1)
Lead Sponsor Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

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