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New blood product could cut transfusions in major surgeries

NCT ID NCT05711524

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a pathogen-reduced version of cryoprecipitate, a blood product that helps blood clot, in 208 patients undergoing liver transplant or heart surgery. The goal was to see if having this product readily available could stop bleeding early and reduce the need for other blood transfusions. Researchers compared it to the standard cryoprecipitate already in use.

What this could mean

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

Active substance
Pathogen-reduced cryoprecipitate (fibrinogen concentrate)
What this could lead to
If it works, this could make a safer, more readily available blood product to control bleeding during major surgeries, reducing the need for other transfusions.
What could go wrong
This is a small pilot study, so results may not apply broadly. The pathogen-reduced product may not work as well as the standard one, and any blood product carries risks like allergic reactions or infection.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

208 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2025

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

Accepted

You do not need to have the condition being studied to take part.

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. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period. 2. Cardiovascular surgery includes the following procedures: 1. coronary artery bypass grafting 2. valve repair or replacement 3. open thoracic aortic and thoracoabdominal aortic surgery 4. atrial or ventricular septal defects 5. ventricular assist device implantation or revision 6. or any combination of the above. Exclusion Criteria: 1. Patients who do not receive any cryo product in the OR 2. Patients who are not cardiovascular surgery or liver transplant patients 3. Cardiac transplantation surgery 4. Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month. 5. Patients who receive less than 1 pool (5 units) of cryo 6. Pediatric patients (less than 18 years of age). 7. Patients who received both PR cryo and traditional cryo 8. Pregnant women

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Conditions

The condition(s) this trial relates to.

acquired coagulation factor deficiency congenital afibrinogenemia familial hypofibrinogenemia Hemorrhage hemorrhagic disease

As listed by the trial registrant

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

Bleeding Hypofibrinogenemia

Contacts and locations

Locations

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065, United States

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