Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

Coagulopathy Clinical Trial

Official title:

Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03700723
• Other study ID #: RSX-201
• Status: Terminated
• Phase: Phase 2
• Start date: December 14, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: January 2021
• Source: Entegrion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders

Intervention

Biological:
• Resusix
spray-dried solvent/detergent treated plasma (blood product)
• FP24 (Frozen Plasma)
plasma frozen within 24 hours of phlebotomy

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Washington University St. Louis	Saint Louis	Missouri
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Entegrion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in INR	Measured as a ratio	120 minutes
Primary	Total incidence of all related SAEs	Count of events	7 days
Secondary	Change in activated partial thromboplastin time (aPTT)	Measured in seconds	72 hours
Secondary	Change in platelet count	Measured in x10.e3/uL	72 hours
Secondary	Change in hemoglobin	Measured in g/L	72 hours
Secondary	Change in clotting function	Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)	72 hours
Secondary	Volume of plasma to correct INR	Measured in mL	72 hours
Secondary	Time to INR reduction below 1.5	Measured in minutes	72 hours
Secondary	Volume of fluid (e.g., crystalloid, colloid, blood component) administered	Measured in mL	72 hours
Secondary	Change in bleeding score in patients with active bleeding	Measured as excellent, good or poor	120 minutes
Secondary	Thrombin generation	Measured in nM	72 hours
Secondary	Serology for human immunodeficiency virus	Measured in IU/mL	95 days
Secondary	Serology for hepatitis	Measured in IU/mL	95 days
Secondary	Change in Sequential Organ Failure Assessment Score (SOFA)	Measured as 0 to 4	96 hours