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

Primary Purpose

Coagulopathy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resusix
FP24 (Frozen Plasma)
Sponsored by
Entegrion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coagulopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Arizona
  • Washington University St. Louis
  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resusix

FP24 (Frozen Plasma)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in INR
Measured as a ratio
Total incidence of all related SAEs
Count of events

Secondary Outcome Measures

Change in activated partial thromboplastin time (aPTT)
Measured in seconds
Change in platelet count
Measured in x10.e3/uL
Change in hemoglobin
Measured in g/L
Change in clotting function
Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)
Volume of plasma to correct INR
Measured in mL
Time to INR reduction below 1.5
Measured in minutes
Volume of fluid (e.g., crystalloid, colloid, blood component) administered
Measured in mL
Change in bleeding score in patients with active bleeding
Measured as excellent, good or poor
Thrombin generation
Measured in nM
Serology for human immunodeficiency virus
Measured in IU/mL
Serology for hepatitis
Measured in IU/mL
Change in Sequential Organ Failure Assessment Score (SOFA)
Measured as 0 to 4

Full Information

First Posted
September 18, 2018
Last Updated
January 6, 2021
Sponsor
Entegrion, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03700723
Brief Title
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Official Title
Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Convenience of Government Funding Sponsor
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entegrion, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
Masking
ParticipantOutcomes Assessor
Masking Description
Single blind
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resusix
Arm Type
Experimental
Arm Description
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.
Arm Title
FP24 (Frozen Plasma)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Resusix
Intervention Description
spray-dried solvent/detergent treated plasma (blood product)
Intervention Type
Biological
Intervention Name(s)
FP24 (Frozen Plasma)
Intervention Description
plasma frozen within 24 hours of phlebotomy
Primary Outcome Measure Information:
Title
Change in INR
Description
Measured as a ratio
Time Frame
120 minutes
Title
Total incidence of all related SAEs
Description
Count of events
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change in activated partial thromboplastin time (aPTT)
Description
Measured in seconds
Time Frame
72 hours
Title
Change in platelet count
Description
Measured in x10.e3/uL
Time Frame
72 hours
Title
Change in hemoglobin
Description
Measured in g/L
Time Frame
72 hours
Title
Change in clotting function
Description
Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)
Time Frame
72 hours
Title
Volume of plasma to correct INR
Description
Measured in mL
Time Frame
72 hours
Title
Time to INR reduction below 1.5
Description
Measured in minutes
Time Frame
72 hours
Title
Volume of fluid (e.g., crystalloid, colloid, blood component) administered
Description
Measured in mL
Time Frame
72 hours
Title
Change in bleeding score in patients with active bleeding
Description
Measured as excellent, good or poor
Time Frame
120 minutes
Title
Thrombin generation
Description
Measured in nM
Time Frame
72 hours
Title
Serology for human immunodeficiency virus
Description
Measured in IU/mL
Time Frame
95 days
Title
Serology for hepatitis
Description
Measured in IU/mL
Time Frame
95 days
Title
Change in Sequential Organ Failure Assessment Score (SOFA)
Description
Measured as 0 to 4
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Galiger
Organizational Affiliation
Entegrion, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

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

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