Use of the Quantra QPlus Sytem in Cardiac Surgery

NCT ID: NCT05501730

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-Quantra

Patients undergoing cardiac surgery prior to the introduction of the Quantra.

No interventions assigned to this group

Post-Quantra

Patients undergoing cardiac surgery after the introduction of the Quantra.

Quantra QPlus System

Intervention Type DIAGNOSTIC_TEST

Coagulation monitoring system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quantra QPlus System

Coagulation monitoring system

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre Tibi, MD

Role: PRINCIPAL_INVESTIGATOR

Yavapai Regional Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yavapai Regional Medical Center

Prescott, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37069685 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEMCS-038

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.