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Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00618098

First Posted: February 18, 2008

Last Update Posted: October 18, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Octapharma

Purpose

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).

Condition	Intervention	Phase
Reversal of Anticoagulant Treatment	Biological: Octaplex (human prothrombin complex concentrate) Biological: Fresh frozen plasma	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Vitamin K

Drug Information available for: Prothrombin Factor IX Complex Thrombin

U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:

There will be two primary end points in this study. The first primary efficacy endpoint is the correction of INR to < 1.5. [ Time Frame: 15 minutes after the end of first infusion of OCTAPLEX or FFP ]

Secondary Outcome Measures:

number of intra-operative red blood cell units (RBC) transfused [ Time Frame: intra-operative ]


Enrollment:	200
Study Start Date:	May 2008
Study Completion Date:	August 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Octaplex (human prothrombin complex concentrate) Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5.	Biological: 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.).
Active Comparator: Fresh frozen plasma Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5.	Biological: 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. Other Name: FFP

Arms

Assigned Interventions

Experimental: Octaplex (human prothrombin complex concentrate)

Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5.

Biological: 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.).

Active Comparator: Fresh frozen plasma

Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5.

Biological: 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.

Other Name: FFP

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.

Eligibility

Information from the National Library of Medicine

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

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.

Contacts and Locations

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): NCT00618098

Locations


United States, Pennsylvania
Contact Octapharma for Facility details
Philadelphia, Pennsylvania, United States, 19141

Sponsors and Collaborators

Octapharma

Investigators


Study Director:	Wolfgang Frenzel, MD	International Medical Director

More Information


Responsible Party:	Octapharma
ClinicalTrials.gov Identifier:	NCT00618098 History of Changes
Other Study ID Numbers:	LEX-205
First Submitted:	February 5, 2008
First Posted:	February 18, 2008
Last Update Posted:	October 18, 2016
Last Verified:	October 2015

Keywords provided by Octapharma:


anticoagulant reversal urgent surgery invasive procedures vitamin K prothrombin complex concentrate

Additional relevant MeSH terms:


Vitamins Vitamin K Thrombin Micronutrients Growth Substances Physiological Effects of Drugs	Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants

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