Coagulopathy
Conditions
Brief summary
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
Interventions
BIOLOGICALResusix
spray-dried solvent/detergent treated plasma (blood product)
BIOLOGICALFP24 (Frozen Plasma)
plasma frozen within 24 hours of phlebotomy
Sponsors
Entegrion, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Single blind
Intervention model description
Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in INR | 120 minutes | Measured as a ratio |
| Total incidence of all related SAEs | 7 days | Count of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin | 72 hours | Measured in g/L |
| Change in clotting function | 72 hours | Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM) |
| Volume of plasma to correct INR | 72 hours | Measured in mL |
| Time to INR reduction below 1.5 | 72 hours | Measured in minutes |
| Volume of fluid (e.g., crystalloid, colloid, blood component) administered | 72 hours | Measured in mL |
| Change in activated partial thromboplastin time (aPTT) | 72 hours | Measured in seconds |
| Thrombin generation | 72 hours | Measured in nM |
| Serology for human immunodeficiency virus | 95 days | Measured in IU/mL |
| Serology for hepatitis | 95 days | Measured in IU/mL |
| Change in Sequential Organ Failure Assessment Score (SOFA) | 96 hours | Measured as 0 to 4 |
| Change in bleeding score in patients with active bleeding | 120 minutes | Measured as excellent, good or poor |
| Change in platelet count | 72 hours | Measured in x10.e3/uL |
Countries
United States
Outcome results
None listed