Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Entegrion, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
SBP 90-150 mm Hg
acquired coagulopathy due to hepatic disease
INR \>1.4
Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure
Written informed consent
MELD score: 25 or less (1st cohort), 35 or less (2nd cohort)
You may not be if
Pregnant women
Incarcerated patients
Life expectancy less than 72 hours
Severe bleeding at time of enrollment
HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies
Receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment
Specific factor inhibitor activity or history of hypersensitivity to plasma-derived products
Receipt of iv heparin within 24 hours of enrollment
Use of a continuous infusion of an intravenous vasoactive medication
Thrombocytopenia
BMI greater than or equal to 40 kg/m2
Participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study
West Haven Hepatic Encephalopathy Grade 3 or 4 (cohort 1) and Grade 4 (cohort 2)
Clareo Health | Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
