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

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ClinicalTrials.gov Identifier: NCT03700723
Recruitment Status : Terminated (Convenience of Government Funding Sponsor)
First Posted : October 9, 2018
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Entegrion, Inc.

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

Condition or disease Intervention/treatment Phase
Coagulopathy Biological: Resusix Biological: FP24 (Frozen Plasma) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Single blind
Primary Purpose: Treatment
Official Title: Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Actual Study Start Date : December 14, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resusix
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.
Biological: Resusix
spray-dried solvent/detergent treated plasma (blood product)

Active Comparator: FP24 (Frozen Plasma)
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.
Biological: FP24 (Frozen Plasma)
plasma frozen within 24 hours of phlebotomy




Primary Outcome Measures :
  1. Change in INR [ Time Frame: 120 minutes ]
    Measured as a ratio

  2. Total incidence of all related SAEs [ Time Frame: 7 days ]
    Count of events


Secondary Outcome Measures :
  1. Change in activated partial thromboplastin time (aPTT) [ Time Frame: 72 hours ]
    Measured in seconds

  2. Change in platelet count [ Time Frame: 72 hours ]
    Measured in x10.e3/uL

  3. Change in hemoglobin [ Time Frame: 72 hours ]
    Measured in g/L

  4. Change in clotting function [ Time Frame: 72 hours ]
    Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)

  5. Volume of plasma to correct INR [ Time Frame: 72 hours ]
    Measured in mL

  6. Time to INR reduction below 1.5 [ Time Frame: 72 hours ]
    Measured in minutes

  7. Volume of fluid (e.g., crystalloid, colloid, blood component) administered [ Time Frame: 72 hours ]
    Measured in mL

  8. Change in bleeding score in patients with active bleeding [ Time Frame: 120 minutes ]
    Measured as excellent, good or poor

  9. Thrombin generation [ Time Frame: 72 hours ]
    Measured in nM

  10. Serology for human immunodeficiency virus [ Time Frame: 95 days ]
    Measured in IU/mL

  11. Serology for hepatitis [ Time Frame: 95 days ]
    Measured in IU/mL

  12. Change in Sequential Organ Failure Assessment Score (SOFA) [ Time Frame: 96 hours ]
    Measured as 0 to 4



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700723


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
United States, Missouri
Washington University St. Louis
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Entegrion, Inc.
Investigators
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Study Director: Michael Galiger Entegrion, Inc.
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Responsible Party: Entegrion, Inc.
ClinicalTrials.gov Identifier: NCT03700723    
Other Study ID Numbers: RSX-201
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders