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New blood clotting drug could cut transfusions in heart surgery

NCT ID NCT07094087

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This phase 3 trial tests a concentrated clotting factor (4F-PCC) against standard fresh frozen plasma to stop bleeding in 200 adults undergoing complex heart surgery with a heart-lung machine. The goal is to see if the new treatment corrects clotting problems faster and more effectively. If it works, it could mean fewer transfusions and better outcomes for patients.

What this could mean

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

Active substance
4-factor prothrombin complex concentrate (BE1116)
What this could lead to
If successful, this could provide a more effective and faster way to control bleeding during complex heart surgeries, reducing the need for transfusions.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to all patients. There is also a risk of blood clots or other side effects with the new treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

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

Started

Sep 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Adult greater than or equal to (≥) 18 years and has provided written informed consent. * Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms. * Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met: * INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility. * Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2. Exclusion Criteria: * Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor / 3-factor PCC \[4F-PCC / 3F-PCC\]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.

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As listed by the trial registrant

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

Complex cardiovascular surgery with cardiopulmonary bypass

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cooper University Healthcare

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • Emory University Hospital

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hospital Civil de Guadalajara

    NOT_YET_RECRUITING

    Guadalajara, Jalisco, 44100, Mexico

  • Johns Hopkins Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kingston Health Science Center

    NOT_YET_RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • London Health Sciences Center - University Campus

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • National Cerebral and Cardiovascular Center

    NOT_YET_RECRUITING

    Suita, Osaka, 564-8565, Japan

  • North Shore University Hospital

    NOT_YET_RECRUITING

    Manhasset, New York, 11040, United States

  • OUHSC (University of Oklahoma Health Sciences Center)

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Oregon Health & Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Sakakibara Heart Institute

    RECRUITING

    Fuchu-shi, Tokyo, 183-0003, Japan

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Health - Ronald Reagan Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)

    RECRUITING

    Montreal, Quebec, H1T1C8, Canada

  • University of Chicago Medicine

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center (KUMC)

    NOT_YET_RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Center (UMMC)

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science

    NOT_YET_RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Virginia Health System

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center (VUMC)

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

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