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Clinical Trials/EUCTR2010-019250-41-AT
EUCTR2010-019250-41-AT
Active, not recruiting
Not Applicable

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 PROTHROMBIN COMPLEX COAGULATION FACTORS (II, VII, IX, X) DEFICIENCY - Efficacy and safety of Prothromplex Total in Reversal of Oral Anticoagulation

Baxter Innovations GmbH0 sites50 target enrollmentApril 21, 2010
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ConditionsAcquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonistsMedDRA version: 14.1Level: LLTClassification code 10037045Term: Prothrombin deficiencySystem Organ Class: 10010331 - Congenital, familial and genetic disorders
DrugsProthromplex TOTAL 600 IU powder and solvent for solution for injection.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists
Sponsor
Baxter Innovations GmbH
Enrollment
50
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 21, 2010
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subject is at least 18 years of age at enrolment with acquired prothrombin complex coagulation factor (II, VII, IX, X) deficiency, due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, invasive procedure or acute bleeding episode
  • •Subject has provided written informed consent
  • •Subject has INR \= 2\.0 at screening
  • •Subject must have been on stable doses of anticoagulant or has a known history of stable INR for at least 72 hours prior to screening
  • •Subject is willing and able to comply with the requirements of the protocol
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Subject has laboratory and/or clinical symptoms which are clearly indicative of 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 PCC constituents (including heparin\-induced thrombocytopenia)
  • •Subject has blood loss of \= 5 units of blood
  • •Subject has known congenital Protein C, Protein S, or Antithrombin deficiency, or hereditary 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 ischaemic cardiovascular disorder
  • •Subject has or is suspected to have sepsis
  • •Subject with acute or chronic liver failure (hepatic cirrhosis Child\-PUGH score C)

Outcomes

Primary Outcomes

Not specified

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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 PROTHROMBIN COMPLEX COAGULATION FACTORS (II, VII, IX, X) DEFICIENCY - Efficacy and safety of Prothromplex Total in Reversal of Oral AnticoagulatioAcquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonistsMedDRA version: 12.1Level: LLTClassification code 10037045Term: Prothrombin deficiency
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