Clinical trial
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
Name
LEX-205
Description
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
Trial arms
Trial start
2008-05-01
Estimated PCD
2012-03-01
Trial end
2012-08-01
Status
Completed
Phase
Early phase I
Treatment
Octaplex (human prothrombin complex concentrate)
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.).
Arms:
Octaplex (human prothrombin complex concentrate)
Fresh frozen plasma
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.
Arms:
Fresh frozen plasma
Other names:
FFP
Size
200
Primary endpoint
INR Response
15 minutes after the end of first infusion of OCTAPLEX or FFP
RBC Transfusion Units
Intra-operative; throughout the duration of operation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-01-31
1 organization
Organization
Octapharma