Study of OCTAPLEX and FFP in Patients Under Vit K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures - Full Text View

Sponsored by:	Octapharma
Information provided by:	Octapharma
ClinicalTrials.gov Identifier:	NCT00618098

Purpose

The purpose of this study is to determine whether Octaplex works at reversing the effects of the anticoagulants when compared to the standard treatment of receiving fresh frozen plasma (FFP).

Condition	Intervention	Phase
Reversal of Anticoagulant Treatment	Drug: prothrombin complex concentrate Biological: Fresh Frozen Plasma	Phase III

MedlinePlus related topics: Blood Thinners Surgery

Drug Information available for: Vitamin K

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

number of intra-operative red blood cell units (RBC) transfused [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	164
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: prothrombin complex concentrate The OCTAPLEX dose will depend on the weight and baseline INR of the patient and will be calculated by the responsible treating investigator based on the dosing formula and the pre-defined INR to a value of <1.5.
2: Active Comparator	Biological: Fresh Frozen Plasma The dose of FFP will depend on the weight and baseline INR of the patient. FFP will be given as a continuous intravenous infusion. The dosage should be 10 mL/kg for a patient that has an initial INR of <3 and 15 mL/kg for a patient that has an initial INR of >3. This will be given over 90 minutes or as fast as clinically indicated or tolerated by the patient at the discretion of the investigator (each unit of FFP contains roughly 200 mL).

Arms

Assigned Interventions

1: Experimental

Drug: prothrombin complex concentrate

The OCTAPLEX dose will depend on the weight and baseline INR of the patient and will be calculated by the responsible treating investigator based on the dosing formula and the pre-defined INR to a value of <1.5.

2: Active Comparator

Biological: Fresh Frozen Plasma

The dose of FFP will depend on the weight and baseline INR of the patient. FFP will be given as a continuous intravenous infusion. The dosage should be 10 mL/kg for a patient that has an initial INR of <3 and 15 mL/kg for a patient that has an initial INR of >3. This will be given over 90 minutes or as fast as clinically indicated or tolerated by the patient at the discretion of the investigator (each unit of FFP contains roughly 200 mL).

Detailed Description:

The primary objective of the study is to demonstrate the efficacy of OCTAPLEX as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures is 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 (e.g. Patients with a GCS [Glasgow Coma Scale] equal to 3 or a head AIS [abbreviated injury score] of 6, patients requiring continuous inotropic or pressor support, patients status post cardiac arrest) (Appendix 7).
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 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 hr 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 and 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618098

Contacts

Contact: Robin Scully, R.N., M.B.A	201-604-1124	robin.scully@octapharma.com
Contact: Toze Reichard	201-604-1125	toze.reichard@octapharma.com

Locations

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

Sponsors and Collaborators

Octapharma

Investigators

Study Director:

Wolfgang Frenzel, MD

International Medical Director

More Information

No publications provided

Responsible Party:	Octapharma USA ( Robin Scully, Director of Clinical Research )
Study ID Numbers:	LEX-205
Study First Received:	February 5, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00618098 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Octapharma:

anticoagulant reversal
urgent surgery
invasive procedures
vitamin K
prothrombin complex concentrate

Study placed in the following topic categories:

Thrombin
Anticoagulants
Vitamins
Vitamin K
Hemostatics

Additional relevant MeSH terms:

Thrombin
Coagulants
Therapeutic Uses

Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on May 07, 2009