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Compares treatment options for Cardiac Disease
Official title Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
ClinicalTrials.gov ID: NCT07032792
What this study is testing
What is FEIBA?
FEIBA is an investigational medicine, being studied as a potential treatment for cardiac disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.