NCT01159210

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prothrombin Complex Factor Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-07-09
• Primary completion: 2012-04-07
• Completion: 2012-04-07
• First posted: 2010-07-09
• Last updated: 2021-05-05

Locations

6 sites across 2 countries: Austria, Hungary