Cardiovascular DiseasesNCT05501730
Use of the Quantra QPlus Sytem in Cardiac Surgery
An observational study of Cardiovascular Diseases, run by HemoSonics LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Quantra QPlus System
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yavapai Regional Medical Center
Prescott, Arizona, 86301
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Quantra QPlus System
- Keywords
- Cardiac surgery, Quantra, Viscoelastic testing, Coagulation, QPlus
- Medical subject headings
- Cardiovascular Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra QPlus SystemDiagnostic test
Coagulation monitoring system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Quantra QPlus System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood product utilization
Units of blood products administered to patient
Measured: Intraoperative - during surgery
Blood product utilization
Units of blood products administered to patient
Measured: 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
Measured: Throughout the entire hospital stay, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Jun 2021
- Primary completion21 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Tibi, MD, Principal investigator, Yavapai Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501730
- Sponsor's protocol ID
- HEMCS-038
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37069685
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05501730
- Acronym / sponsor ID
- HEMCS-038
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac surgery, Quantra, Viscoelastic testing, Coagulation, QPlus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Quantra | – | –Patients undergoing cardiac surgery prior to the introduction of the Quantra. |
| Post-Quantra | – | Diagnostic Test: Quantra QPlus SystemPatients undergoing cardiac surgery after the introduction of the Quantra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery performed by the same surgical team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantra QPlus SystemCoagulation monitoring system | Diagnostic test | Post-Quantra |
Primary outcome
Blood product utilization
Time frame: Intraoperative - during surgery
Units of blood products administered to patient
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
Cost of blood products
Time frame: Throughout the entire hospital stay, assessed up to 30 days
Total cost of blood products administered to patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Derived from this study: PubMed 37069685Tibi 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.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Tibi, MD principal investigator
Yavapai Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by HemoSonics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood product utilization (time frame: Intraoperative - during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.