Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | December 14, 2018 |
| End Date: | November 30, 2020 |
| Contact: | Michael Galiger |
| Email: | mgaliger@entegrion.com |
| Phone: | 9195361500 |
Multicenter, Double-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
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
-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
Inclusion Criteria:
- SBP 90-150 mm Hg
- acquired coagulopathy due to hepatic disease
- INR >1.7
- 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 7
days of enrollment
- Specific factor inhibitor activity or history of hypersensitivity to plasma-derived
products
- Receipt of iv heparin within 24 hours of enrollment
- 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)
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