Quantra System for Hemostatic Disorders

(QUANTRA Trial)

Overseen By Stephanie Stoianoff, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Coagulation disorder, Liver disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery and up to 12 hours post-surgery

666 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Quantra System safe for use in humans?

The Quantra System, including its various versions like the Quantra QPlus and Quantra Hemostasis Analyzer, has been used in clinical settings such as trauma and cardiac surgery without reported safety issues, indicating it is generally safe for human use. ^{1 2 3 4 5}

How is the Quantra Hemostasis Monitoring treatment different from other treatments for hemostatic disorders?

The Quantra Hemostasis Monitoring treatment is unique because it uses a novel ultrasound-based technology called sonic estimation of elasticity via resonance (SEER) sonorheometry to measure the viscoelastic properties of whole blood during coagulation. This allows for real-time, point-of-care assessment of blood clotting, which can be more immediate and informative compared to traditional lab tests. ^{1 2 4 6 7}

What data supports the effectiveness of the Quantra Point-of-Care Hemostasis Monitoring treatment?

Research shows that the Quantra QPlus System, which is part of the Quantra treatment, helps manage blood clotting during surgery by measuring blood's ability to clot quickly and accurately. This has been shown to reduce the need for blood transfusions and manage bleeding more effectively in cardiac surgery patients. ^{1 2 4 8 9}

Who Is on the Research Team?

Andra Duncan, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for complex aortic or high-risk cardiac surgery that requires cardiopulmonary bypass. High-risk surgeries include reoperations, endocarditis, need for circulatory arrest, radiation heart disease, severe kidney disease needing dialysis, multiple valve surgeries or combined valve and bypass procedures, and weak heart function possibly requiring mechanical support.

Inclusion Criteria

I am scheduled for major heart surgery that is considered high-risk.

Exclusion Criteria

Vulnerable patients including prisoners, human fetuses, and neonates

Pregnancy or breastfeeding

Unable to understand English as a first language or unable comprehend the study and/or the consent forms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo complex cardiac surgery with hemostasis monitoring using either routine care or the POC Quantra QPlus System

During surgery and up to 12 hours post-surgery

In-person during surgery and ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative measurements and assessments

During hospitalization, an average of 30 days

In-person during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Quantra Point-of-Care Hemostasis Monitoring

Trial Overview The study aims to see if using the Quantra QPlus System—a point-of-care blood monitoring device—can reduce the need for blood transfusions during and after complex cardiac surgery compared to standard care where transfusion decisions are made by the primary anesthesia provider without this device.

How Is the Trial Designed?

Group I: POC Quantra QPlus System Experimental Treatment 1 Intervention

Perfusion team or trained (certified for POC testing) research personnel will perform hemostasis testing using the Quantra QPlus POC System, results will be interpreted by the primary anesthesia team that will decide if transfusion of blood components is necessary in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).

Group II: Routine Care Active Control 1 Intervention

The primary anesthesia provider will determine the need for blood and blood component transfusion with or without guidance from central laboratory testing for hemostatic abnormalities in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).

Quantra Point-of-Care Hemostasis Monitoring is already approved in United States for the following indications:

Approved in United States as Quantra QPlus System for:

• Cardiac surgery
• Trauma
• Liver transplantation
• Major orthopedic surgeries
• Severe trauma with suspected coagulopathy

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

The Quantra QStat System effectively detected coagulopathies in trauma patients, with 42% of samples indicating a hypocoagulable state and 13% showing hyperfibrinolysis, demonstrating its potential utility in critical bleeding situations.

The study, involving 56 patients at two level 1 trauma centers, found strong correlations between the Quantra QStat parameters and traditional ROTEM assays, suggesting that the Quantra can reliably assess clot stiffness and stability in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the Quantra QStat System in adult trauma patients. Michelson, EA., Cripps, MW., Ray, B., et al.[2022]

The Quantra QPlus System significantly reduced the transfusion of fresh frozen plasma (FFP) by 97% in cardiac surgery patients, indicating its effectiveness in managing blood products during surgery.

Overall, the implementation of the Quantra QPlus System led to a 41% decrease in blood product acquisition costs, saving approximately $40,682, which suggests it can improve both patient outcomes and hospital expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study assessing outcomes in cardiac surgery after implementation of Quantra. Tibi, P., Thompson, J., Attaran, S., et al.[2023]

Point-of-care testing (POCT) for haemostasis analysis provides rapid results, enabling targeted management of bleeding disorders in surgical and critically ill patients, which is crucial for effective treatment.

Despite potentially higher costs, the use of POCT is justified due to improved process quality and time savings, allowing for more precise haemostasis therapy rather than trial-and-error approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Point-of-care testing of hemostatic alterations in anaesthesia and intensive care]. Calatzis, A., Heesen, M., Spannagl, M.[2015]

In a study involving 183 patients undergoing high-bleeding-risk cardiac surgery, the use of a Quantra-guided hemostatic algorithm significantly reduced the number of red blood cell transfusions on the first day after surgery compared to standard laboratory testing.

The Quantra approach also led to a lower incidence of major bleeding on day 1, indicating that this method may enhance patient safety and reduce the need for blood products during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a Quantra-Guided Hemostatic Algorithm in High-Bleeding-Risk Cardiac Surgery. Zlotnik, D., Abdallah, GA., Lang, E., et al.[2023]

The Quantra Hemostasis Analyzer, using SEER sonorheometry, shows strong correlations with ROTEM measurements for assessing clotting parameters in 55 patients undergoing cardiac surgery, indicating its potential as a reliable diagnostic tool for monitoring coagulation status during surgery.

Specifically, Clot Time and Clot Stiffness measured by the Quantra correlate well with established ROTEM metrics, suggesting that SEER sonorheometry can effectively characterize changes in blood coagulation during cardiopulmonary bypass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of SEER Sonorheometry With Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery. Huffmyer, JL., Fernandez, LG., Haghighian, C., et al.[2018]

The Quantra QPlus System is a novel viscoelastic testing device that allows for effective management of coagulation function in critical care settings, designed for use by nonlaboratory personnel at the point-of-care.

Precision testing showed low variability, with total imprecision ranging from 3.6% to 8.0% and repeatability from 2.7% to 7.7%, indicating that the system provides reliable results for coagulation assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique Approach to Quality Assurance in Viscoelastic Testing. Leadbetter, NH., Givens, TB., Viola, F.[2021]

The Quantra® Hemostasis Analyzer shows a strong correlation with conventional coagulation tests, particularly in measuring fibrinogen levels in blood from pregnant women, indicating its potential effectiveness in assessing clot formation.

Specific thresholds for Quantra® variables, such as a Fibrinogen Contribution to Clot Stiffness (FCS) value of 2.45 and Clot Stiffness (CS) value of 10.85 hPa, can accurately predict clinically relevant fibrinogen levels, suggesting its utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of sonorheometry point of the care device in determining low fibrinogen levels in pregnant blood: an invitro dilution and reconstitution study. Kodali, BS., Karuppiah, A., Bharadwaj, S., et al.[2022]

The Quantra device, which uses a novel ultrasound-based technology called sonorheometry, is being tested for its effectiveness in managing bleeding in cardiac surgical patients, comparing its performance to the established ROTEM/Multiplate system.

This study aims to demonstrate that the new Quantra-based treatment algorithm is not inferior to the existing ROTEM-based algorithm, with a threshold of less than 150 mL of cumulative blood loss within 24 hours post-surgery, based on an initial analysis of blood samples from 20 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial. Michel, S., Piekarski, F., Fischer, JH., et al.[2020]

The Quantra device shows a very strong correlation with traditional clot firmness measurements, indicating its effectiveness in assessing coagulation in cardiac surgery patients, with correlation coefficients (r values) ranging from 0.94 to 0.96.

The Quantra-derived platelet contribution to stiffness (PCS) is significantly associated with both platelet count and function, suggesting that it can provide valuable insights into platelet activity during coagulation assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of SEER Sonorheometry Versus Standard Coagulation Tests, Rotational Thromboelastometry, and Multiple Electrode Aggregometry in Cardiac Surgery. Baryshnikova, E., Di Dedda, U., Ranucci, M.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the Quantra QStat System in adult trauma patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Retrospective study assessing outcomes in cardiac surgery after implementation of Quantra. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Point-of-care testing of hemostatic alterations in anaesthesia and intensive care]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of a Quantra-Guided Hemostatic Algorithm in High-Bleeding-Risk Cardiac Surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of SEER Sonorheometry With Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Unique Approach to Quality Assurance in Viscoelastic Testing. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of sonorheometry point of the care device in determining low fibrinogen levels in pregnant blood: an invitro dilution and reconstitution study. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of SEER Sonorheometry Versus Standard Coagulation Tests, Rotational Thromboelastometry, and Multiple Electrode Aggregometry in Cardiac Surgery. [2020]