FEIBA versus fresh frozen plasma as first-line treatment for bleeding after cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares FEIBA (a bypassing agent) with standard fresh frozen plasma (FFP) as the first-line transfusion for coagulopathic microvascular bleeding following cardiopulmonary bypass in non-emergent, non-coronary cardiac surgery. Eligible adults who develop microvascular bleeding requiring factor transfusion are treated with either FEIBA or FFP and monitored for control of bleeding and clinical outcomes. Key exclusions include disseminated intravascular coagulation, acute thrombosis or embolism, known coagulation disorders, pregnancy, or patients on ECMO or with VADs or recent transplants. The trial is conducted at a single center (North Shore University Hospital) and aims to determine whether FEIBA provides faster or more complete correction of coagulopathy and reduces bleeding-related complications compared with FFP.

Why it matters

Who can join: the full rules

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

Where it's running

• North Shore University Hospital
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Pey-Jen Yu — Northwell Health
• Study coordinator: Kristine McGowan
• Email: kmcgowan@northwell.edu
• Phone: 516-881-7035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.