Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal

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. Identifier: NCT01159210
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : October 23, 2017
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.

Condition or disease Intervention/treatment Phase
Prothrombin Complex Factor Deficiency Biological: Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multi-centre, Prospective, Open-Label, Non-Randomised, Uncontrolled Study to Assess the Efficacy and Safety of Prothromplex Total in Oral Anticoagulant Reversal in Patients With Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X)
Study Start Date : July 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Intervention Details:
  • Biological: Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)
    Intravenous infusion; regimen is guided by the pre-treatment international normalised ratio (INR); dosage and duration of replacement therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient´s clinical condition.
    Other Name: Prothromplex Total

Primary Outcome Measures :
  1. Proportion of subjects who achieve normalisation of International normalised ratio (INR) to <= 1.3 within 30 (±5) minutes post administration of Prothromplex Total [ Time Frame: within 35 minutes after administration of study drug ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
  • Subject or parent/legally authorised representative has provided written informed consent
  • Subject has INR >= 2,0 at screening
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
  • Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
  • Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
  • Subject has blood loss of >= 5 units of blood
  • Subject has hereditary thrombophilia or bleeding disorder
  • Subject has a life expectancy of < 3 months
  • Subject has been on oral anticoagulant treatment for a period of < 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
  • Subject has an acute ischemic cardiovascular disorder
  • Subject has or is suspected to have sepsis
  • Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
  • Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

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 identifier (NCT number): NCT01159210

Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6807
Universitätsklinik für Innere Medizin I (University Hospital for Internal Medicine I), Allgemeines Krankenhaus der Stadt Wien (General Hospital Vienna)
Vienna, Austria, 1090
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, Austria, 1130
DEOEC, University of Debrecen, Medical and Health Science Centre
Debrecen, Hungary, 4032
Fejer Megyei Szent György Korhaz
Szekesfehervar, Hungary, 8000
Veszprem Megyei Csolnoky Korhaz Nonprofit Zrt., Belgyógyászati Centrum, Haematológiai Részleg
Veszprem, Hungary, 8200
Sponsors and Collaborators
Baxalta now part of Shire
Study Director: Neil Inhaber, MD Baxter Healthcare Corporation

Responsible Party: Baxalta now part of Shire Identifier: NCT01159210     History of Changes
Other Study ID Numbers: 220901
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: September 2012

Additional relevant MeSH terms: