New blood clotting drug could cut transfusions in heart surgery

NCT ID NCT07094087

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

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

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.

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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

Contacts and locations

Locations

Hospital Civil de Guadalajara
NOT_YET_RECRUITING

Guadalajara, Jalisco, 44100, Mexico
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
NOT_YET_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
NOT_YET_RECRUITING

Dallas, Texas, 75390, United States
Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)
NOT_YET_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 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 Virginia Health System
NOT_YET_RECRUITING

Charlottesville, Virginia, 22908, United States

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