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Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

RecruitingPhase 2Ages 18 Years - anyAllNorthwell Health
NCT07032792 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.

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📋 Eligibility rules (as published)
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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What it tests

  • FEIBA
  • FFP
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Where

1 site
North Shore University Hospital
Manhasset, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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