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?

This trial tests a new tool, the Quantra QPlus System, to determine if it can reduce the need for blood transfusions during and after complex heart surgeries. The goal is to compare this system, which provides quick blood clotting information, to the usual method of deciding on transfusions based on lab tests. Adults scheduled for high-risk heart surgery, especially those with conditions like kidney disease or heart infections, are a good fit for this trial.

As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve surgical outcomes.

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.

What prior data suggests that the Quantra QPlus System is safe for use in cardiac surgery patients?

Research has shown that the Quantra QPlus System aids doctors in understanding how a patient's blood clots, which proves very useful during surgeries. The FDA has approved the system for specific situations, indicating it meets certain safety standards.

The Quantra System performs a quality check every 8 hours and before each test to ensure accurate results. This self-checking process ensures the reliability of the information it provides.

Regarding safety, the device does not require medication or procedures. It analyzes blood samples to assist doctors in deciding on blood transfusions. Since the FDA has cleared it for certain situations, it is generally considered safe for its intended purpose.

Overall, the Quantra QPlus System is well-tolerated, with no reports of direct negative effects from the device itself. However, as with any medical tool, participants should feel comfortable asking questions about its use in their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Quantra Point-of-Care Hemostasis Monitoring system is exciting because it offers real-time, bedside insights into a patient's blood clotting ability during and after surgery, something current methods like standard lab tests can't provide as quickly. Unlike traditional lab testing, which can take hours to return results, the Quantra system delivers rapid information, helping doctors make faster decisions about blood transfusions. Researchers are eager to see if this system can improve patient outcomes by reducing unnecessary transfusions and associated risks, potentially leading to more efficient and safer surgical procedures.

What evidence suggests that the Quantra QPlus System is effective for hemostatic disorders?

Research has shown that the Quantra QPlus System, which participants in this trial may receive, is promising for checking blood clotting during surgery. This system uses special ultrasound technology to assess blood clotting, aiding doctors in deciding whether a blood transfusion is necessary. Studies have found that it works well alongside standard blood tests, allowing for quick and accurate assistance during surgery. Early results suggest it might reduce the need for blood transfusions in complex surgeries. Overall, it serves as a helpful tool for monitoring blood health during operations. ^{1 2 5 6 7}

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 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]

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 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]

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]

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]

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 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]

Citations

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Discover the Quantra® Hemostasis System

A new way to look at coagulation. Patented SEER Sonorheometry uses novel ultrasound technology to measure viscoelasticity of a whole blood sample.

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Quantra Point-of-Care Hemostasis Monitoring

The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary ...

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sciencedirect.com/science/article/pii/S0959289X24003376

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We found a strong correlation between Quantra QStat parameters and standard coagulation tests during PPH. Quantra parameters during PPH enable rapid and ...

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Multicenter Evaluation of the Quantra QPlus System in ...

The Quantra QPlus System can be used as alternative to current viscoelastic testing devices to monitor coagulation function in the perioperative settings.

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Quantra System for Hemostatic Disorders

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 ...

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DEN180017 summary - accessdata.fda.gov

The Quantra QPlus System is an in vitro diagnostic device designed to assess a patient's coagulation status by measuring the shear modulus of a blood sample ...

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FDA Grants HemoSonics 510(k) Clearance to Expand Use ...

The Quantra Hemostasis System delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data ...