New drug may stop bleeding after heart surgery better than standard care
NCT ID NCT07032792
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two treatments for bleeding after heart surgery: FEIBA (a special clotting medicine) and fresh frozen plasma (standard care). About 140 adults having non-emergency heart surgery will be enrolled. The goal is to see if FEIBA reduces the need for blood transfusions more effectively than the standard approach.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 years or above * Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass * Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team Exclusion Criteria: * Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components * Disseminated intravascular coagulation * Acute thrombosis or embolism, including myocardial infarction * Pregnancy * Patients that are not able or do not want to consent for themselves * Patients with known coagulation disorders * Patients who received coronary artery bypass surgery * Patients who received transplants or ventricular assist devices * Patients on extracorporeal membrane oxygenator support * Patients with heparin induced thrombocytopenia * Patients who do not wish to receive blood products even when it is deemed medically necessary
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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North Shore University Hospital
RECRUITINGManhasset, New York, 11030, United States
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