Bleeding, Cardiac Disease, Surgery
Conditions
Brief summary
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.
Interventions
DRUGFEIBA
Subjects randomized to FEIBA will receive up to 2 vials of 500U of FEIBA through a preexisting central line at a rate that does not exceed 2 units per kg of body weight per minute for the study intervention.
DRUGFFP
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total post-treatment pRBC transfusion within 24 hours of surgery | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total pRBC transfusion after administration of study drug | From time of administration of study drug until time of discharge or up to 3 months, whichever comes first. | — |
| Total units of posttreatment platelet transfusion within 24 hours of surgery | 24 hours | — |
| Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery | 24 hours | — |
| Total units of FEIBA given within 24 hours of surgery | 24 hours | — |
| Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery | 24 hours | — |
| Total mLs of chest tube output within 12 hours of surgery | 12 hours | This is being assessed as chest tube output may be an indicator of ongoing bleeding |
| Incidence of adverse postoperative events | Perioperative | This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis. |
| Length of intubation | Perioperative | — |
| Length of hospital stay | From date of hospital admission until date of discharge or up to 3 months, whichever comes first. | — |
| 30-day mortality | 30 days | — |
Countries
United States
Contacts
CONTACTKristine McGowan
PRINCIPAL_INVESTIGATORPey-Jen Yu
Northwell Health
Outcome results
None listed