Cardiac DiseasePhase 2NCT07032792
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
A Phase 2 study testing FEIBA and FFP in people with Cardiac Disease and Surgery, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Surgery, Bleeding
- What is being tested?
- FEIBA and FFP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Kristine McGowan
About this study
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.
- Conditions
- Cardiac Disease, Surgery, Bleeding
- Being tested
- FEIBA, FFP
- Medical subject headings
- Heart Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEIBADrug
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.
FFPDrug
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
| Study group | Role | What they receive |
|---|---|---|
| FEIBA | Experimental | Not described Receives: Drug: FEIBA |
| FFP | Active comparator | Not described Receives: Drug: FFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post-treatment pRBC transfusion within 24 hours of surgery
Measured: 24 hours
Secondary outcomes (10)
Total pRBC transfusion after administration of study drug
Measured: 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
Measured: 24 hours
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery
Measured: 24 hours
Total units of FEIBA given within 24 hours of surgery
Measured: 24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery
Measured: 24 hours
Total mLs of chest tube output within 12 hours of surgery
This is being assessed as chest tube output may be an indicator of ongoing bleeding
Measured: 12 hours
Incidence of adverse postoperative events
This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.
Measured: Perioperative
Length of intubation
Measured: Perioperative
Length of hospital stay
Measured: From date of hospital admission until date of discharge or up to 3 months, whichever comes first.
30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start3 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pey-Jen Yu, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032792
- Sponsor's protocol ID
- 24-0293
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 24-0293
- Conditions
- Cardiac Disease, Surgery, Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEIBA | Experimental | Drug: FEIBA |
| FFP | Active comparator | Drug: FFP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEIBASubjects 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. | Drug | FEIBA |
| FFPSubjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line. | Drug | FFP |
Primary outcome
Total post-treatment pRBC transfusion within 24 hours of surgery
Time frame: 24 hours
10 secondary outcomes
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.
Total units of posttreatment platelet transfusion within 24 hours of surgery
Time frame: 24 hours
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery
Time frame: 24 hours
Total units of FEIBA given within 24 hours of surgery
Time frame: 24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery
Time frame: 24 hours
Total mLs of chest tube output within 12 hours of surgery
Time frame: 12 hours
Incidence of adverse postoperative events
Time frame: Perioperative
Length of intubation
Time frame: Perioperative
Length of hospital stay
Time frame: From date of hospital admission until date of discharge or up to 3 months, whichever comes first.
30-day mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pey-Jen Yu principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FEIBA and FFP in people with Cardiac Disease and Surgery, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine McGowan (516-881-7035, kmcgowan@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total post-treatment pRBC transfusion within 24 hours of surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.