Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
spray-dried solvent/detergent treated plasma (blood product)
plasma frozen within 24 hours of phlebotomy
University of Arizona
Tucson, Arizona, United States
Washington University St. Louis
St Louis, Missouri, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Change in INR
Measured as a ratio
Time frame: 120 minutes
Total incidence of all related SAEs
Count of events
Time frame: 7 days
Change in activated partial thromboplastin time (aPTT)
Measured in seconds
Time frame: 72 hours
Change in platelet count
Measured in x10.e3/uL
Time frame: 72 hours
Change in hemoglobin
Measured in g/L
Time frame: 72 hours
Change in clotting function
Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)
Time frame: 72 hours
Volume of plasma to correct INR
Measured in mL
Time frame: 72 hours
Time to INR reduction below 1.5
Measured in minutes
Time frame: 72 hours
Volume of fluid (e.g., crystalloid, colloid, blood component) administered
Measured in mL
Time frame: 72 hours
Change in bleeding score in patients with active bleeding
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measured as excellent, good or poor
Time frame: 120 minutes
Thrombin generation
Measured in nM
Time frame: 72 hours
Serology for human immunodeficiency virus
Measured in IU/mL
Time frame: 95 days
Serology for hepatitis
Measured in IU/mL
Time frame: 95 days
Change in Sequential Organ Failure Assessment Score (SOFA)
Measured as 0 to 4
Time frame: 96 hours