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New Blood-Clot monitor could cut transfusions in heart surgery

NCT ID NCT06328647

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a bedside device called Quantra can help doctors decide when to give blood transfusions during complex heart surgery. The device measures how well a patient's blood clots in real time. Researchers hope this will reduce the number of blood products (like red cells, plasma, and platelets) given during and right after surgery. The trial involves 666 adults having high-risk heart surgery at the Cleveland Clinic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quantra QPlus System (point-of-care device)
What this could lead to
If successful, this could reduce the need for blood transfusions during complex heart surgery, lowering risks and improving recovery.
What could go wrong
This is a single-center trial, and results may not apply to all hospitals. The device may not significantly change transfusion rates compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 666 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 years or more 2. Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass (high-risk surgery includes reoperative surgery, active endocarditis, expected need for intraoperative circulatory arrest, radiation heart disease, end-stage kidney disease requiring renal replacement therapy, combination surgery including more than one valve or valve plus CABG, low left ventricular ejection fraction \[EF\<30%\] with potential need for mechanical circulatory support with intra-aortic balloon pump, extracorporeal membrane oxygenation \[ECMO\], pulmonary thromboembolectomy or percutaneous left ventricular assist device (VAD), and planned placement of a durable left VAD with or without placement of RV assist device. Exclusion Criteria: 1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder 2. Preoperative abnormal coagulation disorder (platelet count below 100,000/uL and/or aPTT \>40 seconds in the absence of heparin therapy. Prolonged aPTT \>40 seconds in the acceptable if due to heparin therapy.) 3. Liver disease, defined as a history of cirrhosis, liver enzymes \>3x normal range or manifested by elevated PT suggesting abnormal liver synthetic function not explained by other comorbidities 4. Pregnancy or breastfeeding 5. Refusal to accept red blood cells and blood component transfusions. 6. Contraindications to proposed interventions. 7. Unable to understand English as a first language or unable comprehend the study and/or the consent forms. 8. Vulnerable patients including prisoners, human fetuses, and neonates

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Conditions

The condition(s) this trial relates to.

aortic disorder coronary artery disorder end stage renal failure endocarditis heart failure heart valve disorder Hemorrhage hemorrhagic disease pulmonary embolism vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleeding Hemostatic disorder

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

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