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

ConditionsCardiac DiseaseSurgeryBleeding
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FEIBA

    Drug

    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.

  • FFP

    Drug

    Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: FEIBAExperimental treatment 1 intervention
Group B: FFPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total post-treatment pRBC transfusion within 24 hours of surgery

Time frame
24 hours

Secondary outcomes

1

Total pRBC transfusion after administration of study drug

Time frame
From time of administration of study drug until time of discharge or up to 3 months, whichever comes first.
2

Total units of posttreatment platelet transfusion within 24 hours of surgery

Time frame
24 hours
3

Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery

Time frame
24 hours
4

Total units of FEIBA given within 24 hours of surgery

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
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