Your session is about to expire
← Back to Search
Blood Product
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Phase 2
Waitlist Available
Research Sponsored by Entegrion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
No Placebo-Only Group
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
Eligible Conditions
- Blood Clotting Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in INR
Total incidence of all related SAEs
Secondary study objectives
Change in Sequential Organ Failure Assessment Score (SOFA)
Change in activated partial thromboplastin time (aPTT)
Change in bleeding score in patients with active bleeding
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ResusixExperimental Treatment1 Intervention
The experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.
Group II: FP24 (Frozen Plasma)Active Control1 Intervention
The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.
Find a Location
Who is running the clinical trial?
Entegrion, Inc.Lead Sponsor
3 Previous Clinical Trials
387 Total Patients Enrolled
Michael GaligerStudy DirectorEntegrion, Inc.