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Clotting drug may replace plasma transfusions in heart surgery

NCT ID NCT04244981

Disease control Sponsor: SHI Jia 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 compared two treatments to reduce bleeding after heart valve surgery: a concentrated clotting drug (PCC) versus fresh frozen plasma (FFP). The trial planned to enroll 476 adults undergoing elective valve surgery. It was terminated early, so the full comparison was not completed.

What this could mean

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

Active substance
Prothrombin Complex Concentrate (PCC)
What this could lead to
If it works, this could offer a faster, more standardized way to control bleeding after heart valve surgery, potentially reducing the need for plasma transfusions.
What could go wrong
This trial was terminated early, so results are limited. It is a non-inferiority study, meaning it only aims to show PCC is not worse than plasma, not that it is better. Bleeding risks and side effects like clotting are possible.

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

476 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 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 to 80 years

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. Age between 18 and 80 years. 2. Undergoing elective valve repair, valve replacement or complex valvular surgery through CPB. 3. Signing of the informed consent form. 4. A combined assessment of plasma activated partial thromboplastin time (plasma-aPTT) and activated clotting time (ACT) is performed 20 minutes after heparin neutralization following CPB. We considered patients who meet the following criteria to have post-CPB coagulation factor deficiencies: (1) at least moderate bleeding, as determined using a validated bleeding severity scale; (2) a targeted ACT within ±10% of baseline; and (3) a plasma-aPTT exceeding 45 seconds or more than 1.5 times baseline. The requirement could be waived when bleeding was severe and required immediate intervention. Exclusion Criteria: 1. History of cardiac surgery. 2. Severe hepatic and renal dysfunction before surgery. 3. Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders. 4. Patients undergoing emergency surgery in whom discontinuation of anticoagulant therapy was not feasible \[INR \> 1.2（or above upper normal limit）after discontinued use of warfarin; withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery, etc\]. 5. Allergy to allogeneic blood products. 6. Pregnancy. 7. Other serious diseases that may affect patient survival time, such as cancers.

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Conditions

The condition(s) this trial relates to.

heart valve disorder hemophilia B

As listed by the trial registrant

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

Cardiac surgical procedures Valvular heart surgery

Contacts and locations

Locations

  • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    Beijing, Beijing Municipality, 100037, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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