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Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

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ClinicalTrials.gov Identifier: NCT02740335
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

Condition or disease Intervention/treatment Phase
Significant Bleeding Risk Drug: Octaplex Drug: Beriplex P/N (Kcentra) Phase 3

Detailed Description:

The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitami n K Antagonist (VKA)therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

The secondary objective of the study is to investigate the safety and tolerability of OCTAPLEX compared to Beriplex® P/N (Kcentra) in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex® P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Vitamin K

Arm Intervention/treatment
Experimental: Octaplex
Participants to receive1 Octaplex infusion intravenously
Drug: Octaplex
OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min).
Other Names:
  • 4F PCC
  • 4 Factor PCC
  • 4 Factor Prothrombin Concentrate Complex

Active Comparator: Beriplex P/N (Kcentra)
Participants to receive1 Kcentra infusions intravenously
Drug: Beriplex P/N (Kcentra)
Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min).
Other Name: Kcentra




Primary Outcome Measures :
  1. Hemostatic efficacy rating [ Time Frame: At the end of surgery ]
    Efficacy will be rated by the investigator at the end of the surgery in a blinded manner based on a 4-point hemostatic efficacy scale taking into account blood loss and transfusion requirements in the context of the surgery.


Secondary Outcome Measures :
  1. Correction of international normalized ratio (INR) to < 1.5 [ Time Frame: 30 minutes after the end of infusion ]
    Number of patients with an international normalized ratio (INR) value of less or equal to 1.5 at 30 min (± 15 min) after the end of infusion.

  2. Coagulation Factor Levels [ Time Frame: 30 minutes after the end of infusion ]

    Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:

    o Factor II


  3. Coagulation Factor Levels [ Time Frame: 30 minutes after the end of infusion ]

    Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:

    o Factor VII


  4. Coagulation Factor Levels [ Time Frame: 30 minutes after the end of infusion ]

    Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:

    o Factor IX


  5. Coagulation Factor Levels [ Time Frame: 30 minutes after the end of infusion ]

    Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:

    o Factor X


  6. Number of patients requiring Red Blood Cells (RBC) [ Time Frame: through study completion, an average of 5 years ]
    Number of patients receiving red blood cells (RBC) during the surgery



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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

  1. Male or female patients at least 18 years of age.
  2. Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
  3. Patients being admitted to the hospital or currently hospitalized where:

    • an urgent surgery carrying significant bleeding risk (≥50 mL expected blood loss) is required as part of routine clinical care;
    • the use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal;
  4. Patients with an international normalized ratio (INR) of 2.0 or above at the time of decision to reverse the anticoagulation status.
  5. Patients who have given written informed consent and who are able and willing to comply with the procedures described in the study protocol.

Exclusion Criteria

  1. Patients with a life expectancy of less than 48 hours per physician's judgment (e.g. patients with a Glasgow Coma Scale equal to 3 or a Head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
  2. Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g. catheter placement, gastroscopy).
  3. Patients with a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within 3 months of enrollment.
  4. Patients with a known congenital bleeding disorder.
  5. Patients with a known antiphospholipid antibody syndrome.
  6. Patients with present or past specific factor inhibitor activity.
  7. Patients with thrombocytopenia of <80,000/μL or history of heparin-induced thrombocytopenia.
  8. Patients who have received heparin of any type or any non-VKA anticoagulant within 24 hours prior to enrollment into the study or with potential need to receive these medications before completion of hemostasis evaluation at the end of surgery.
  9. Patients who have received prothrombin complex concentrates (PCCs), fresh frozen plasma or vitamin K within 72 hours prior to enrollment into the study.
  10. Patients with a known history of hypersensitivity to plasma-derived products.
  11. Patients with acute major bleeding or polytrauma.
  12. Pregnant or nursing women.
  13. Patients participating in another interventional clinical study currently or during the past 30 days prior to enrollment into this study.
  14. Patients previously enrolled in this study.

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): NCT02740335


Contacts
Contact: Mikaela Grupp 866-337-1868 ctgov@clinicalresearchmgt.com

  Show 68 Study Locations
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Wolfgang Frenzel International Medical Monitor

Publications:
Campbell P, Roberts G, Eaton V. Managing warfarin therapy in the community. Aust Prescriber 2001; 24:86-89.
Cushman M, et al. Clinical Practice Guide on Antithrombotic Drug Dosing and Management of Antithrombotic Drug-Associated Bleeding Complications in Adults, American Society of Hematology, 2014.

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02740335     History of Changes
Other Study ID Numbers: LEX-209
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Octapharma:
anticoagulant reversal
urgent surgery
invasive procedures
vitamin K
prothrombin complex concentrate
four-factor prothrombin complex concentrate (4F-PCC)

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Vitamins
Vitamin K
Thrombin
Protein C
Protein S
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anticoagulants
Fibrinolytic Agents