- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00618098
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.
The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Contact Octapharma for Facility details
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients at least 18 years of age.
- Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
- Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
- Patients with an international normalized ratio (INR) of 2.0 or above.
- Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
- Patients able and willing to comply with the procedures laid out in the study protocol. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol.
Exclusion Criteria:
- Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
- Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
- Patients with a known congenital coagulation disorder.
- Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
- Patients with present or past specific factor inhibitor activity.
- Patients with thrombocytopenia of < 80,000 or a history of heparin induced thrombocytopenia (HIT).
- Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion.
- Patients who have received vitamin K more than 3 hours prior to the infusion of study drug.
- Patients with a history of hypersensitivity to plasma-derived products.
- Pregnant or nursing women.
- Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
- Patients previously enrolled in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Octaplex (human prothrombin complex concentrate)
Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
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INR is determined 15 minutes after the end of each infusion.
Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52.
The maximum dose for initial treatment was not to exceed 5500 IU.
If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5.
Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.).
|
ACTIVE_COMPARATOR: Fresh frozen plasma
Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
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INR is determined 15 minutes after the end of each infusion.
The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3.
If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5.
Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INR Response
Time Frame: 15 minutes after the end of first infusion of OCTAPLEX or FFP
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Number of patients who had an INR response, defined as the correction of patient's INR to <1.5, 15 minutes after the end of first infusion with study medication
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15 minutes after the end of first infusion of OCTAPLEX or FFP
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RBC Transfusion Units
Time Frame: Intra-operative; throughout the duration of operation
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Total number of intra-operative units of red blood cell (RBC) given to patients
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Intra-operative; throughout the duration of operation
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wolfgang Frenzel, MD, International Medical Director
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEX-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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