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

NCT00618098 | Completed Phase 3 Results DMC

• 1 other identifier: LEX-205
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Reversal of Anticoagulant Treatment

Keywords

anticoagulant reversal; urgent surgery; invasive procedures; vitamin K; prothrombin complex concentrate

Outcome Measures

Primary Outcomes (2)

• INR Response

  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

  15 minutes after the end of first infusion of OCTAPLEX or FFP

• RBC Transfusion Units

  Total number of intra-operative units of red blood cell (RBC) given to patients

  Intra-operative; throughout the duration of operation

Study Arms (2)

Octaplex (human prothrombin complex concentrate)

EXPERIMENTAL

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

Biological: Octaplex (human prothrombin complex concentrate)

Fresh frozen plasma

ACTIVE COMPARATOR

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

Biological: Fresh frozen plasma

Interventions

Octaplex (human prothrombin complex concentrate) BIOLOGICAL

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.).

Octaplex (human prothrombin complex concentrate)

Fresh frozen plasma BIOLOGICAL

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.

Also known as: FFP

Fresh frozen plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 previously enrolled in this study.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (1)

Contact Octapharma for Facility details

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Hemophilia B

Interventions

prothrombin complex concentrates

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Results Point of Contact

• Title: Patrick Murphy
• Organization: CRMG

p.murphy@crmg-usa.com

4138210022

Study Officials

• Wolfgang Frenzel, MD

  International Medical Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Locations

US (1)