NCT05501730

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

June 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

July 26, 2022

Last Update Submit

August 12, 2022

Conditions

Cardiovascular Diseases

Keywords

Cardiac surgeryQuantraViscoelastic testingCoagulationQPlus

Outcome Measures

Primary Outcomes (3)

  • Blood product utilization

    Units of blood products administered to patient

    Intraoperative - during surgery

  • 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

  • Cost of blood products

    Total cost of blood products administered to patient

    Throughout the entire hospital stay, assessed up to 30 days

Study Arms (2)

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

Interventions

Quantra QPlus SystemDIAGNOSTIC_TEST

Coagulation monitoring system

Post-Quantra

Eligibility Criteria

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

Patients undergoing cardiac surgery performed by the same surgical team.

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Yavapai Regional Medical Center

Prescott, Arizona, 86301, United States

Location

Related Publications (1)

  • Tibi P, Thompson J, Attaran S, Black E. Retrospective study assessing outcomes in cardiac surgery after implementation of Quantra. J Cardiothorac Surg. 2023 Apr 17;18(1):149. doi: 10.1186/s13019-023-02245-x.

    PMID: 37069685DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesThrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular Diseases

Study Officials

  • Pierre Tibi, MD

    Yavapai Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 15, 2022

Study Start

June 15, 2021

Primary Completion

November 21, 2021

Study Completion

December 15, 2021

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)