Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal - Full Text View

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Malnutrition

Drug Information available for: Factor IX Thrombin

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	61
Study Start Date:	July 2010
Study Completion Date:	June 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159210

Locations

Austria
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
Hungary
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

Baxter Healthcare Corporation

Investigators

Study Director:

Neil Inhaber, MD

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01159210 History of Changes
Other Study ID Numbers:	220901
Study First Received:	July 8, 2010
Last Updated:	September 13, 2012
Health Authority:	Austria: Agency for Health and Food Safety Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:

Anticoagulants
Thrombin
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on May 23, 2013