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Recruiting NCT07032792

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

Phase II Interventional Cardiac Disease Surgery Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FEIBA, FFP.
Who it may be relevant to
Registry conditions: Cardiac Disease, Surgery, Bleeding. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Total post-treatment pRBC transfusion within 24 hours of surgery [Time frame: 24 hours]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • North Shore University Hospital — Manhasset

Identifiers

NCT: NCT07032792 · 24-0293

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗